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FDA eSubmitter User Manual

1. Previous FDA eSubmitter 98 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Printing Locating and Copying Files Locate the Submission Files on the Computer s Hard Drive FDA eSubmitter User Manual v5 1 Submission Files 2 Click Done to close the Packaging Files Dialog Done box OR Click Previous to return to Step 3 Sous The following instructions do not apply if you are transmitting your submission via the Electronic Submissions Gateway Please see FDA ESG for Gateway transmission instructions If you are transmitting your electronic submission on CD follow the instructions below After packaging the files for submission locate the packaged zip file on your computer and copy it onto a CD In addition you will need to mail the signed submittal letter printed in Step 3 of the eSubmitter Packaging Submission Files Process NOTE For an OIVD submission the truth and accuracy statement is part of the letter To locate submission files on the computer s hard drive follow the instructions below Action 1 Use Windows Explorer to navigate to the label for the computer s installed hard drive e g Local Disk C For example on a computer with Windows 2000 e Open Windows Explorer e Double click My Computer to display its contents e Look for the label of the computer s installed hard drive For example C3 2 Double click on the label for the hard
2. FDA eSubmitter 4 User Manual v5 1 Introduction Output Menu Commands FDA eSubmitter User Manual v5 1 Subsection 3 3 Menu Bar Output The Output menu includes commands related to the output of reports for submission information For complete information on getting a submission ready to send to FDA see Completing a Submission on page 85 Output Tools Help Missing Data Report Submission Report Submittal Letter HP Package Files for Submission Note All report outputs are generated as Rich Text and require an application capable of viewing output such as a WEB browser the full version of Adobe Acrobat not Acrobat Reader or Microsoft Word Each command on the Output menu is described below Tool Function Missing Provides a list of required questions that you have not yet Data answered The list is provided in Rich Text format You can Report save the report file at any time However you will not be able to package a submission file to submit to FDA until there is no missing data For complete information see Subsection 4 4 Completing a Submission on page 85 Blank Views prints a blank submission form in Rich Text Report Form Submission Views prints out the submission report with your entries in Rich Report Text Submittal Provides a formatted cover letter in Rich Text for you to sign Letter that identifies your file and must be submitted along with the CD and any hardc
3. Address Line 2 City State Province or Territory Post Office or Zip Code Phone Numbers Telephone number Fax number Cancel gt Click the Mailing Location tab to enter address information for the mailing address of the organization FDA eSubmitter 4A User Manual v5 1 Edit Delete Close Help FDA eSubmitter User Manual v5 1 Organization Identification PhysicalLocation Mailing Location Copy the physical location to the mailing location Gom Arion j Address Country United States of America Other select below Address Line 1 Address Line 2 City State Province or Territory v j Post Office or Zip Code Phone Numbers Telephone number a Bt l Fax number aa OK it Cancel it Help Copy Address see gt Click if the mailing location is the same as the physical location of the organization The information is automatically copied into the address fields as shown above However if the mailing location differs drastically from the physical location you must manually enter the information gt When you are finished with the addresses click ok to save your edits Click Cancel to ignore all edits or Het to see help text You return to the Address
4. Displays tabs that organize the report into sections as shown below a 6 al S o e o o a 2 3 5 81 9 Submission Name Sample Supplement Submission Last Modified Report Type Radiation Emitting Product OMB No 0910 0025 Date Packaged Outline Screen Submission Information 3 Product Data What Type of Submission is this Supplements should be submitted selecting the same document type as the original eRadHealthMenu Manufacturer Data report 2 Role Radiation Safety Report Product Report and Supplements X 2 Submission Information p p pp What Type of Product is this Annual Report about What Type of Correspondence is this i EE E What Type of Product is this Radiation Safety Report about J Laser Products Includes Projection Systems ai what Type of Productis this Variance Request about What Laser Light Show Document are you filing Each tab within the outline has an image to the left of its descriptive text This image depicts which tab contains the section that is currently displayed within the screen area 1 e the tab with the highlighted green image Each section within the outline contains a folder image to the left of the section text This folder image depicts the status of required information that is missing from within the question responses of the sect
5. 2 Submission Hams ampio fuapeionent Suh Last Modifier n pratt Ne pE Radiato ag Product OME ho 0810 00255 Gmn P w i i oo i Te WE Tye Of Gaubie gaa a as Suppa debe be SubMmidd Scleching he gamit documen pe ad Fee Ongind eftatiteatn Men 3 Manufacture Data rapo Roa Submission mrii in HELE i What Type of Product is this Annual Repon about Spl itter Bar What Type of Compepondanca ia Bia FDA eSubmitter User Manual v5 1 Whal Typa of Product i thie Radiation Galat Repel acu C Lasit Products mcpu Y ec aes F Whal Tepe of Product is ihis Yaniinte Requesl about Wheat Lager Ligh Show Docement are you fling 39 Introduction FDA eSubmitter User Manual v5 1 Subsection 3 2 Toolbar Bead 5 0 G 6 0 SAA The tool bar is a row of buttons that are designed to provide quick access to specific or commonly used commands and options The tool bar is located below the menu bar Note The screens and information that are accessed through the icons can also be accessed using the following menus File Edit View and Help However you must access information for Output and Tools with the exception of Package Files for Submission through the actual menus For information relating to output and tools functions refer to pages 42 and 43 respectively The buttons on the tool bar are grouped by functionality and are described below Tool Function E New Displays the New Template
6. An example is shown below Screen List of Tobacco Products By Brands Detail View Parent Reference Name Sample Name Parent Sub Reference Name Sample Sub Name Product By Brands 9 List Detail AddNew Delete Delete tC ttem 2 Brand Details Product Category P v Product Category Sub Type Enter Brand Family Name d Enter Brand Name 9 Enter Proprietary Name for Brand 2 Enter Alternate Trade Name s for Brand if applicable To see the items in the table click Details If you accidentally enter a blank into the table by clicking Add New not responding to any FDA eSubmitter 79 User Manual v5 1 Item Number FDA eSubmitter User Manual v5 1 Subsection 4 3 Relationships Across Screens questions and then clicking Details you will see a line of colored blank spaces Select the line of colored spaces and click the Delete button to remove the item from the table If you have added multiple entries you will note that in the Detail or in the Add New view the Item Number highlighted below will change based on the Item Number as seen in the List view above Screen List of Tobacco Products By Brands Parent Reference Name Sample Name Parent Sub Reference Name Sample Sub Name Product By Brands List l Detail AddNew Delete
7. Delete ttem 2 Brand Details Product Category 3 Snuff Product Category Sub Type Enter Brand Family Name P Coppenhagen Enter Brand Name Y Coppenhagen Wintergreen Enter Proprietary Name for Brand e Coppenhagen Wintergreen Enter Alternate Trade Name s for Brand if applicable 80 Subsection 4 3 Relationship Across Screens Relationships Some tabbed and or panel screens may be linked together through a parent child Across Parent relationship follow the instructions below and Child Screens If this parent child relationship exists you will see a header bar on the child screens as seen below indicating which list item within the parent table you are currently entering data for These child screens will be repeated for each list entry in the parent table as necessary Relationship Screen List of Tobacco Products By Brands Header Parent Reference Name Sample Name Parent Sub Reference Name Sample Sub Name Product By Brands ViewList ViewDetail AddNew Delete ODeleteal 3 tem 1 Brand Details Product Category 9 Sub Type of Product Enter Brand Family Name Enter Brand Name ey Enter Proprietary Name for Brand A Enter Alternate Trade Name s for Brand if applicable gt i w 0 of 10 items in the list A a
8. For information on setting up your PDF Viewer see page 21 Note The file list is specific to the submission that 1s currently open thus not retained nor accessible for future reports The Master File Attachment Dialog box manages the file attachment information related to the open submission The dialog box contains a list of all the attached files that are currently available an area for general information on the selected file and options for managing the list The file list displays the following for each e Descriptive title e Physical file name e Number of questions that currently reference the file as an attachment e File date e File size 47 Adda New File View Manage File List View Edit Delete Close w Changes Tools Assign Submission ID FDA eSubmitter User Manual v5 1 Subsection 3 4 Menu Bar Tools e Path to the file location The options provided in the dialog box are described below Allows you to add a new file to the Master File Attachment list for later use as a question response For instructions on how to attach files as a question response see How to Attach a File to an Attachment Question Type beginning on page 60 Allows you to manage the existing documents in the list of files displayed in Step 2 The options available for managing the list of existing files include View Edit Delete and Close These options are described below Displays the selected file within the
9. OK box The PDF that you just added is automatically displayed in the fields in Step 2 14 Click Attach Selected File s You see the path Attach Selected File location of the file selected appear in the file attachment question This question type allows you to attach multiple files as a response Below is an example of an attachment question with a file attachment included In the image below the green plus sign is still enabled after attaching a file indicating that additional files may be attached as the response To attach multiple PDF files to an attachment question follow the same instructions listed under How to Attach a File to an Attachment Question Type beginning on page 60 Attach labelts 2 items in the list Title Name Date Scroll Bar to view additional details on files Sample Attachment 1 Sample_Attachmentt odf O8fee005 05 21 44 Fh Sample Attachment 2 Sample_Attachment2 odf 08022005 03 1 7 6 Pa 64 Subsection 4 2 4 Question Types Guidance Documents Guidance This question type allows you to select the guidance Documents documents that you used to prepare your submission as well as provides space for you to add supporting text if necessary Below is an example of a guidance document question Please enter all referenced Guidance Documents Qa 0 items in the list Document Title Select a To select a guidance document follow the instructions below Guidance Document Ac
10. Output Submittal Letter gf estate Ee View Print Submittal Letter Attach Signed Submittal Letter CADocuments and SettingsiMy DocumentsiLetter pdf EJ FDA eSubmitter 96 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Produce To produce a submission package follow the instructions below Submission Package Always available Action Graphic Package Submission Files oe Click on J to initiate the packaging of the zip file as shown below Produce Submission Package Y Package Submission Files gio 2 NOTE Once the submission has packaged successfully the status bar will indicate that the packaging is complete as shown below Produce Submission Package Y Package Submission Files Complete Large Very large submissions may be broken up into multiple packaged zip files In Submission Size that case the following confirmation statement will be displayed Confirmation Message a The submission was packaged successfully However due to the size of the content itwas splitinto multiple separate files Please make sure to include all of the following files when submitting to FDA CiDocuments and SettingsieSub Homelpackageimooodse O01 zip CDocuments and Settingsie Sub HomelpackagelMloudser O02 zip CDocuments and SettingsieSub HomelpackageilMoouuse O03 zip The submission will be incomplete until all files are received by FDA Ifyou
11. Product By Brands e 2 List of Tob Products ands 22 List et Tobacea Prodes 9y Brends List Detail Aiid hw Deet Detete All 3 E ah Sub Brand Details Packaging Lewi E ah Sub Brand Packaging Information i of Br Labeling Statement FB Advertising information gt fem Product Category Product Category Sut Type Brand Name Bc nsumes Product inforrnatior 1 Cigarette Mariboro Lights 100 s bh Establishment Retationship 2 Snuf Coppenhagen Wintergreen Fl F Components Manufactured by Third Party In the right side of the screen seen above the product category cigarette is selected As you move through to the child folder Sub Brand Details Packaging Level and after entering the appropriate data you will see the following information in the List view Note that a new header is displayed in green that reminds you which parent in this case the product category and brand you are entering information for Product Category amp Brand Cigarette Marlboro Click NEW to add details for each Sub Brand being listed Y List Detail Add New Delete Delete alt o Table of Sub Brands gt Item Sub Brand Name Sub Brand Proprietary Name 1 Marlboro Lights 100 s Marlboro Lights 100 s 2 Marboro Regular 100 s Marboro Regular 100 s Once you enter information for one sub brand and have reached the end of the parent child relationship a dialogue box as seen below will prompt the user if they woul
12. This will aid the reviewer in locating information and navigating the submission e Bookmark references can be created for the heading of a section subsection or title of figures and tables within the document In general including a bookmark to the main table of contents for a submission or item is helpful Make the bookmark hierarchy identical to the table of contents e Use hyperlinks within the file Hyperlinks are used to improve navigation through PDF documents and are encouraged Hyperlinks can be designated by rectangles using thin lines or by blue text or you can use invisible rectangles for hypertext links in a table of contents to avoid obscuring text Hyperlinks throughout the body of the document to supporting annotations related sections references appendices tables or figures that are not located on the same page are helpful and improve navigation efficiency When creating bookmarks and hyperlinks the magnification setting should be set to Inherit Zoom so that the destination page displays at the same magnification level that the reviewer is using for the rest of the document Important Note Hyperlinks between individual PDF document files are not currently supported and any absolute links that reference across files will not work In general for documents with a table of contents provide bookmarks and hypertext links for each item listed in the table of contents including all tables figures publications other refe
13. Check the list to ensure that all of the appropriate file attachments are listed only files referenced in responses will be included See above for an example 2 Check the question counts to confirm that the files are attached gt NOTE If a file appears to be missing from the list go to the Submission File List within eSubmitter File Menu gt Tools gt Submission File List In the Master File List ensure that each file is attached to a question A zero in the Question Count column indicates that the file is not attached to a specific question and therefore will not be included in the packaged submission 3 Check the file dates size and locations to ensure the correct versions of the files are provided 4 Click Next to proceed to Step 3 and continue Next packaging the submission e OR Click Previous to go back to Step 1 Previous OR Cancel and exit the Package File Dialog box FDA eSubmitter 93 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Step 3 oe sae P oe This section will differ based on the submission you are filing Transmission Approach If a specific step listed below does not appear in the dialog box on your screen Submittal this is because it does not apply Please skip the instructions and move to the Letter and next step displayed on the Packaging Files Dialog box Below is an example Packaging of what may appe
14. Dialog box which allows a new empty template to be created Open Displays the Open Existing Template Dialog box 3 which allows an existing template to be selected and opened LJ Save Saves any changes within the open template to permanent storage e g to the disk Simple Layout Selects the simple layout which displays the current data entry screen and contains basic options for moving forward and backward through the report one screen at a time Expert Layout Selects the expert layout which contains the overall outline and current data entry screen side by side Home Takes you to the home screen B 40 Subsection 3 2 Toolbar Previous Navigates to the previous screen Next Navigates to the next screen Process Screen Changes Processes your changes to screens without saving the template or selecting another node This option allows you to see how rules impact the form based on the changes made without having to leave the screen Screen Undo Undoes most recent changes made Cut Cuts text Copy Copies text Paste Pastes text 6 e e Package Files for Submission Packages your submission to send to FDA after you have completely answered all required questions For complete information see Packaging Submission Files on page 90 Help Contents Displays the Help Menu which includes the User Manual Quick Guide and FAQs
15. Model images A captured image should not be subjected to non uniform scaling i e sizing Files with scanned images and photographs tend to be large in file size Please do not exceed 100MB for a single file Consider multiple files for these types of documents Note Scanned tables and graphs cannot be extracted easily if scanned Most OCR programs will distort the data in tables and graphs Convert MS Word documents to PDF as this method usually retains the formatting For a paper document with handwritten notes Paper documents containing handwritten notes should be scanned at 300 dpi These handwritten notes should be made in black ink for Clarity lf you have questions about creating electronic copies please contact technical support at cvmesubmitter fda hhs gov 113 Naming PDF We suggest uniformity be used when naming files When naming Files files do not use punctuation spaces or other non alphanumeric symbols in file names when naming the files for attachments For example do not use slashes tildes asterisks periods brackets single quotation marks double quotation marks or parentheses Once the file is attached to a question it can be selected as an attachment to other questions if appropriate The eSubmitter tool supports the following file types e Portable Document Format Files pdf e Excel Files xls csv e SAS System XPORT Files xpt e Media Files wm
16. Selecta A 8 Verify that the correct file type is selected in the Files of Type drop down located below the File Name field Only those files of the type chosen will appear in the display pane for you to select The Files of Type is defaulted to Adobe Acrobat Files pdf Note The Files of Type drop down field may not be enabled if the question has been set to restrict the response to only allow a particular file type e g PDF only 9 Click the Look In drop down menu to locate the drive such as Local Disk C or folder where the file you wish to attach is stored 10 When you locate the desired file click to select it highlight The name of the file appears in File Name as shown below FDA eSubmitter 63 User Manual v5 1 Subsection 4 2 3 Question Types File Attachments Select File Dialog Box File Selected Multiple File Attachments FDA eSubmitter User Manual v5 1 K Select File Lookin C eSub l A El MRA Ci data J JExpress manual EI META INF CI Output 4 submission pdf File Name submission paf Files of Type Adobe Acrobat Files pdf kd Select l Cancel 11 Click Select The Select File dialog box closes and Splect you return to the New File dialog box 12 Enter a title in Descriptive title required entry and a description in General description if desired 13 Click OK You return to the File Attachment Dialog
17. a Submission to Open Submission Name File Name Last i Sample Submission Sample Submission xml 01 14 2009 04 View the Description of the Selected Submission Create New Submission Open Cancel 2 Click to select highlight the submission that you wish to open and click Open The selected submission is displayed Open FDA eSubmitter User Manual v5 1 33 FDA eSubmitter User Manual v5 1 Section 3 Interface Contents This section contains the following topics Application Window a Toolbar Menu Bar Output M Menu Bar Tools O 8B 34 Introduction Simple View Screen Area Navigation Bar FDA eSubmitter User Manual v5 1 Subsection 3 1 Application Window This section describes eSubmitter s Application Window and its different parts The eSubmitter Application Window has two layouts that change the orientation of the text on the screen simple and expert When you first start up the application eSubmitter opens in the simple layout with the screen view The simple view shows only the current data entry screen and hides the outline tree The simple view separates the Submission Display Screen into three additional areas as shown below Header Area located at the top o Outline Area or Screen Area located in the middle Navigation Bar located at the bottom which allows forward and backward movement through the screens as well as th
18. a response properly attached See instructions for correctly attaching files in the subsequent section Provide supporting details and an attachment if necessary Location of Fi le File 2 ey eS tachment CADocuments and Settings 515899 Desktopisampleattachmentsitestattach pdf Attachment Details Paragraph v alalis EA 2 EME lt q Indicates Rich This file describes the tabel Text Editor 59 Su How to Attach a File to an Attachment Question Type File Attachment Dialog Box FDA eSubmitter User Manual v5 1 bsection 4 2 3 Question Types File Attachments To attach a file as a response to an attachment question in eSubmitter follow the instructions outlined below Action Graphic 1 Click the Add File icon to select the desired file to da attach as the question response The File Attachment Dialog wizard is displayed as shown below E File Attachment Dialog Attach File to Response Step 1 Select the Method for Identifying the File to Attach Select a File from a List of Previously Attached Files O Select a New File from the Workstation or Network Select the File to Attach from the List List of Previously Attached Files Ee Name Question Count 0 files in the list General Description ofthe Selected Files Close w Changes 2 Step 1 Select the Method for Identifying the File to Attach In this step choose the desired method for selecting the f
19. and structure and in some cases it can affect the information conveyed by a document We cannot guarantee the availability of any one font Therefore you should embed all fonts you are using in the PDF files to ensure that those fonts will always be available to the reviewer When embedding fonts all characters for the font should be embedded not just a subset of the fonts being used in the document One problem associated with embedding fonts is that embedding requires additional computer storage space Three techniques to help limit the storage space taken by embedding fonts e Limit the number of fonts used in each document e Use only True Type or Adobe Type 1 fonts e Avoid customized fonts Resizing a document because the contents are too small to read is inefficient We believe that Times New Roman 12 point font is adequate in size for reading narrative text This is the preferred font Although sometimes tempting for use in tables and charts fonts smaller than 12 points should be avoided whenever possible We recommend the use of a black font color 103 User Manual v5 1 Section 5 FDA Recommended PDF File Specifications Blue font may be used or hypertext links If a font color other than black is used avoid light colors that do not print well on grayscale printers It is advised that you test the color reproduction prior to submission by printing sample pages from the document using a grayscale printer In addition to fo
20. ay Previous Next Cancel Follow these instructions to set up your PDF viewer FDA eSubmitter 21 User Manual v5 1 Subsection 2 2 Setting User Preferences Action Graphic 1 Click the Select Location icon to the right of the text box The Select Viewer Application File box is a displayed as shown below Select Viewer Ej Select Viewer Application File fx Application File a oki ese E 5 eSubmitter exe D Uninstall exe File Hame Files of Type Program Executable Files ba Pe e 2 Click in the Look In box and navigate to the file folder for Adobe Acrobat or the Acrobat Reader The location is usually either e Program Files gt Adobe gt Acrobat gt Acrobat exe e Program Files gt Adobe gt Reader gt AcroRd32 exe 3 Highlight select Acrobat exe or AcroRd exe and click Select Select The File Viewer tab in the User Preferences Dialog box will appear in the text box as shown below FDA eSubmitter 92 User Manual v5 1 User Preferences Dialog Box Messages FDA eSubmitter User Manual v5 1 Subsection 2 2 Setting User Preferences Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to what applications are used to view attached files Adobe pdf Viewer C Program Files AdobelAcrobat 8 0 AcrobatiAcrobat exe of Previous Next Cancel 4 Click OK OK Allows you to indicate whe
21. be warned if the file that they are attempting to open is currently in use hy another Enable File Lacking E Previous I Next OK Cancel To enable file locking follow the instructions below Action Graphic 1 Click to select the Enable File Locking checkbox to iv turn file locking on or clear the checkbox to turn file locking off FDA eSubmitter 18 User Manual v5 1 File Location FDA eSubmitter User Manual v5 1 Subsection 2 2 Setting User Preferences Action Graphic 2 Ifyou want to change the settings for networking Next click Next or the File Location tab See the description for File Location below OR If you are finished and satisfied with your changes click OK to close the User Preferences Dialog box with your changes saved OK OR Click Cancel to close the User Preferences Dialog ____ box without saving any changes Cancel Allows you to change the location where your report data files are stored when saved and the location where files are generated when output e g reports and packaged submissions For more information on packaging files for submission go to Package Files for Submission on page 90 User Preferences Dialog Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to the location of application files A The Data Location identifies where report data files are stored when saved Data Location _ CADocuments a
22. bookmarks and hypertext links are essential for the efficient navigation through documents PDF documents produced by scanning paper documents are usually inferior to those produced from an electronic source document such as MS Word Scanned documents are more difficult to read and do not allow the reviewers to search or copy and paste text for editing The use of scanned documents should be avoided if at all possible If scanning cannot be avoided the following is highly recommended e Perform optical character recognition OCR on all scanned documents so that the text is searchable e Check to see that the content has been correctly converted If the source document is only available on paper it should be scanned at resolutions that will ensure the pages are legible both on the computer screen and when printed if necessary At the same time remember to limit the file size to be less than 100MB We recommend scanning at a resolution of 300 dots per inch dpi to balance legibility and file size After scanning avoid re sampling to a lower resolution For files with images and photographs Also when creating PDF files containing images you should not resample images Re sampling does not preserve all of the pixels in the original For photographs the image should be obtained with a resolution of 600 dpi If black and white photos are submitted consider 8 bit gray scale images If color photos are submitted consider 24 bit RGB Color
23. box is displayed OO FDA eSubmitter 70 User Manual v5 1 Subsection 4 2 6 Question Types Product Codes Product Code K Product Code Filter Dialog Filter Dialog Provide Product Code filter criteria Box Product Code Name keyword search Device Class Classification Panel CER Section Identifier ji qP Name Matching Product Codes Product Code Product Code Name Device Class Cle 0 Product Codes in the list Clear Filter Select Cancel 2 Enter a keyword to search the database You will be provided a list of product codes from which to choose in the Matching Product Codes portion of the dialog box 3 To further refine your search if desired e Click the Device Class drop down list and make a selection e Click the Classification Panel drop down list and make a selection e Click the Select Item icon next to the Identifier under C F R Selection and make a selection Clear Filter e Click to remove entries and start the search over again FDA eSubmitter 71 User Manual v5 1 Subsection 4 2 6 Question Types Product Codes 4 Click to highlight the best match to your select product device and click an You return to the submission screen and the product code question The remaining fields in the product code question are filled in for you as shown below Choose the product code for this
24. communication and speed the review of a submission File names should not contain more than 250 characters Do not use punctuation spaces or other nonalphanumeric symbols in file names when naming the files for attachments For example do not use slashes tildes asterisks periods brackets single quotation marks double quotation marks or parentheses Once the file is attached to a question it can be selected as an attachment to other questions if appropriate The eSubmitter tool supports the following file types Portable Document Format Files pdf Excel Files xls csv SAS System XPORT Files xpt Media Files wmv avi Image Files gif tif Jpg Extensible Markup Language Files xml dtd Archive Compressed Files zip Standard Generalized Markup Language Files sgml MDL Molfiles Files mol However based on the application or report you are submitting the question s may have restrictions on which file types you are allowed to attach For example some questions may allow you to attach any of the file types supported be eSubmitter and some may only allow you to attach PDF and Excel files as the questions response or supporting documentation FDA eSubmitter 107 User Manual v5 1 Introduction FDA eSubmitter User Manual v5 1 Section 6 User Support For technical assistance for the eSubmitter software an email can be sent to esubmitter fda hhs gov In th
25. drive to display its contents 3 Navigate to and double click on the Program Files file folder to open 99 Subsection 4 5 Completing a Submission Packaging Submission Files Action 4 Navigate to and double click on the eSub file folder to open 5 Double click on the output file folder to open The zip file that you created in Packaging Submission Files appears Do not modify the zip file after it is generated by eSubmitter FDA eSubmitter 100 User Manual v5 1 FDA eSubmitter User Manual v5 1 This step will differ based on the submission you are filing Some programs accept a digital signature and submission via the Electronic Submissions Gateway and others require submission via CD ROM and handwriting signatures As of March 2011 the following is acceptable for each participating program CDER Program ICSR Drug Adverse Event Submissions Digital signatures are not accepted at this time for ICSR Drug Adverse Event submissions The CDER program only accepts submissions via the FDA Electronic Submissions Gateway CDRH Programs OIVD s 510 k Digital signatures are not accepted at this time for OIVD 510 k submissions In the future the digital signature will be available in conjunction with the FDA Electronic Submissions Gateway ESG Radiological Health Reports and Correspondence Digital signatures are accepted and required when utilizing the FDA ESG to submit reports and correspondence See note below regarding
26. information in text fields and make selections using drop down menus and clicking option buttons An example is shown below Other types of address questions are Contact and Multi Part Address which will be discussed below Address Country amp United States of America Other select below C es Phone Numbers Telephone number i Ext ammer We Contact Simple This question type requires that you type contact information first name last name etc in text fields Entries may or may not be required The figure below shows an example of a simple contact question with the first name last name and email address as required fields as indicated by the blue dots Contact This question type contains multiple sections that you need to Multi complete indicated by the tabs Contact Information Part Establishment Identification Physical Location and Mailing FDA eSubmitter 53 User Manual v5 1 Subsection 4 2 1 Question Types Address and Contact Information Location For this question type you may enter contact information first name last name etc directly into text fields or you may copy this information from the Contact Book When you enter the information directly without using the Contact Book the contact information is only saved for the submission Copying the information from the Contact Book saves time for data entry because the information is automatically copie
27. layout use the buttons on the navigation bar to advance to next return to previous screen e If you are in the expert layout use the outline pane and activate each section to load the screen or the navigation arrows located on the tool bar FDA eSubmitter 51 User Manual v5 1 Question Types FDA eSubmitter User Manual v5 1 Subsection 4 1 Entering Submission Information 3 Provide a response to the question s on the screen The response required depends on the type of question The eSubmitter tool uses several different types of questions to capture all the information that is required for a specific report The response that you enter depends on the type of question used in your particular report For example to answer a specific question you may be required to select a response from a drop down box type in text attach a separate PDF file select a check box or provide contact information The following subsections describe each of the different question types and include examples of their respective responses Note You may not see all of these types of questions in one particular report The purpose of this section is to provide a brief overview of all of the different question types that are used in the eSubmitter software 32 Subsection 4 2 1 Question Types Address and Contact Information Address This question type requires that you enter the address and phone numbers of your organization You enter the
28. methods for creating a new submission report starting from scratch with a completely blank report or copying an existing report and making the required changes The purpose for copying an existing report would be to save time assuming many of the responses are the same This might be the case if you have an existing report from the same product line or you are submitting a supplement The steps involved for both are provided below Follow the steps below to create a new blank submission from scratch Action Graphic 1 The eSubmitter application should be open on your computer desktop If it is open and you see the Intro Screen go to step 2 If it is not open open the application first by following the instructions in Starting the Software on page 8 26 Subsection 2 3 Creating a New Submission Action Graphic 2 Click the Create New Submission button from the Menu Options Or you may select File gt New or click the New Report icon on the Tool Bar The New Submission Dialog box is displayed as shown below E K New Submission Dialog E Create New Submission Create New Submission Step 1 Select a Submission Type List of Available Submission Types Name Version Version Date CBER Pilot Source Plasma BLA Submission 12 09 2008 09 44 10 jal in Vitro Diagnostic Device 510k 08 28 2008 04 02 16 F MedvVatch Form 35004 OMB No 0910 0291 j 11 05 2008 09 52 6 AN Radiation Emitting Product OMB No 0910 002
29. sa Enter Multiple To enter multiple three letter codes in the product code question follow the Three Letter instructions below Codes in the cps aye Product Code Note The Product Code is specific to those filing with the Center for Devices Question and Radiological Health Action Graphic 1 Ifyou know the three letter code assigned to your product device enter it in the Product Code text box You see the product code device appear in Product Codes matching the specified filter criteria as shown below FDA eSubmitter 73 User Manual v5 1 Subsection 4 2 6 Question Types Product Codes Product Codes matching the specified fitter criteria ProductGode Product Code Name Device Class Classificatio BRT RESTRAINT PATIENT CONDUCTIVE CLASS GENERAL a BR PROTECTOR DENTAL CLASS ANESTHESIO 2165 Product Codes in the filtered list 2 Click Select The product device appears in Product Select Codes currently selected as shown below Product Codes currently selected Froduct code Product Code Name Device Class Classificatio BRT RESTRAINT PATIENT CONDUCTIVE CLASS GENERAL HOSS 3 Repeat steps 1 and 2 to continue to add product codes OR e If you do not know the three letter code see the instructions below to search for the code OR e Click OK to return to the multiple product codes question OK Search Multiple To search for multiple three letter codes by keyword follow the instruct
30. specified PDF viewer Displays the Edit File Dialog box which allows the selected file title and general description to be changed Deletes the selected file from the list Closes the dialog box and saves the changes made to the Master File Attachment list Function Allows you to enter an FDA related identifier to a submission After you have sent the submission to the FDA for processing and if you have received a unique identifier you may store that FDA assigned identifier in the submission for tracking purposes For complete information on preparing a submission see page 50 To enter a Report ID Select Assign Submission ID from Tools on the Menu bar You see the Assign Submission ID dialog box see below Enter the unique identifier assigned by FDA 48 If you are satisfied with your entry click OK Or click Cancel to close the dialog box without making any changes Afer a submission is received and processed you will receive an acknowledgement with a Unique submission identifier This identifier should be used whenever referring to this submission OK Cancel FDA eSubmitter 49 User Manual v5 1 FDA eSubmitter User Manual v5 1 Section 4 Preparing a Submission Contents This section contains the following topics gt TextFieldsandMessages 68 50 Subsection 4 1 Entering Submission Information Introduction Entering information for a submission requires stepping thro
31. submission Product Code Name STOOL ANESTHESIA oe Classification Panel ANESTHESIOLOGY CFR Section 06g 6r ANESTHESIA STOOL Product This question type allows you to identify other product codes Codes applicable to the submission Below is an example of a multiple Multiple product code question 2 items in the list ProductCode Product Code Mame Device Cl REJ LASER TOYIMOVELTY PRODUCT UNCLAS SIF Ley LASER MEWUROSURGICAL CLASS III Add Product To add product codes follow the instructions below Codes Action Graphic 1 Click the Add Product Code icon You see the da Product Codes Filter Dialog box as shown below a FDA eSubmitter T9 User Manual v5 1 Subsection 4 2 6 Question Types Product Codes Product Code I Product Code Filter Dialog Filter Dialog 7 Provide Product Code filter criteria keywords Box i Product Code Product Code Name Device Class zj Classification Panel e C F R Section Identifier j Name Product Codes matching the specified filter criteria Product Code Product Code Name Device Class Classificatio 0 Product Codes in the filtered list Product Codes currently selected Product Code Product Code Name Device Class 0 Product Codes in the selected list Clear Filter 2 Enter Product Code and Product Code Name in the appropriate sections 3 Click OK
32. tab 4 Ifthe information is not exactly the same you can edit the information in the question fields after you have copied it gt To see the other information click on the desired tab If you copied the contact information from the Contact Book the information for these tabs will be completed as well 6 For more information about Contact Books see page 53 FDA eSubmitter 55 User Manual v5 1 Subsection 4 2 2 Question Types Option Lists Drop Down Menu Radio Button Check Box Check Box Group List Item FDA eSubmitter User Manual v5 1 This question type requires that you select a response from a list of entries that appear after you click the box with the down arrow Below is an example of a question with a drop down menu What type of product is this submission referring to e In Vitro Diagnostic Device Radiation Emitting Product Other This question type requires that you click on the radio button to select a question response Only one response can be selected See the example below Will you be utilizing the same SOPs in all of your facilities E Yes C No _ Not Applicable This question type requires that you click on the box to select or clear the check mark to answer a question See the example below Compliance with the limits of 217 CFR would restrict the intended use ofthe product because compliance would limitthe output power to the extent t
33. the FDA ESG RadHealth Submissions utilizing the eSubmitter software may still also be burned to CD and mailed to CDRH in lieu of using the ESG eMDR MedWatch 3500A Form The eMDR program accepts digital signatures and utilizes the FDA ESG or transmission of the submission package eMDR submissions may only be sent through the FDA Gateway CBER Program OBRR BLA BLS Submissions Digital signatures are accepted and required for signing the necessary FDA OMB forms Form 356h and Form 2567 when applicable However the CBER program does not accept submissions via the FDA Electronic Submissions Gateway at this time CTP Program Tobacco Establishment Registration Product Listing and Health Data Submissions Digital signatures are accepted and required when utilizing the FDA Electronic Submission Gateway to submit registration listing and additional health data CVM Program ONADE Digital signatures are accepted and required when utilizing the FDA Electronic Submission Gateway to submit eSubmitter electronic submissions to CVM For additional information please refer to the Quick Guide Packaging and Transmission Guidelines for Participating eSubmitter Programs 101 Section 5 FDA Recommended PDF File Specifications Introduction Regulations in 21 CFR Part 11 require that the Agency be able to generate from any document provided in electronic format an accurate and complete paper copy that is both legible human readable an
34. the changes to the response were still in effect If you have auto save turned off in Preferences these changes are only saved permanently when you select the Save option from the tool bar or File menu Therefore follow the same guidance that you would use when saving data in other software In other words whenever you have entered an amount of data that would be frustrating to have to re enter select the save option For information on changing auto save preferences see page 15 Note The software will remind you to save if data has been changed and you are about to perform an operation that would result in losing your changes such as opening another submission or exiting the application To save a submission follow the instructions below Action Graphic 1 Click File gt Save OR Click the Save icon on the tool bar bed If you do not finish entering information into a submission in one session you may return to it at another time See Reopening an Existing Submission on page 33 2 If you wish to close the submission click File gt Close The ntro Screen is then displayed 84 Introduction Missing Data Report Output Dialog Box FDA eSubmitter User Manual v5 1 Subsection 4 4 Completing a Submission To complete a submission you must identify 1f any data is missing from your report and then enter the required data package the files for submission find the necessary files on your computer and cop
35. the initial view as Page only Set the Page Layout and Magnification fields to default 111 Document Properties Security Indexing PDF Documents Bookmarks and Hypertext Links FDA eSubmitter User Manual v5 1 PDF files are stored as original documents and will not be altered from their original form Remove any security settings read only or password protection used on the files Files submitted with security settings will not be accepted Full text indexes are used to help find specific documents and or to search for text within documents When a document or group of documents is indexed all words and numbers in the file and all information stored in the Document Information fields are stored in special index files that are functionally accessible using the search tools available in Acrobat Portions of a document that are imaged are not indexed Even if the document only contains images the text in the Document Information fields of the file will be indexed All PDF files should be full text searchable prior to submitting to the FDA Bookmarks and hyperlinks should be used to assist the reviewers in navigating through the content of the submission If you used either bookmarks or hypertext links consider the following Use meaningful bookmarks e g the title of the section name of a study data set or facility This will aid the reviewer in locating information and navigating the submission Bookmark references c
36. use of additional plug ins other than those provide by Adobe as part of Acrobat We should not need any additional software to read and navigate the PDF files There are features in Adobe Acrobat 8 0 that cannot be supported If you would like to submit Adobe Acrobat 8 0 files please contact technical support at esubmitter fda hhs gov to ensure you do not use a feature that is unsupported It is acceptable to use plug ins to assist in the creation of a submission However the review of the submission should not require the use of any plug ins other than any provided by Adobe as part of Acrobat and must be compatible with Adobe Acrobat 5 0 or greater The print area for pages should fit on a sheet of paper that is 8 5 inches by 11 inches You should allow a margin of at least 1 5 inch on the left margin and 1 inch on all other sides to avoid obscuring information if the pages are subsequently printed and bound Pages should be properly oriented For example you should set the page orientation of landscape pages to landscape prior to saving the PDF document in final form to ensure correct page presentation Landscape pages including tables should be oriented such that the header and footer of the document align with the right edge of the page PDF viewing software automatically substitutes a font to display text if the font used to create the text is unavailable on the reviewer s computer Font substitution can affect a document s appearance
37. 5 12 05 2008 11 46 40 A Report of Assembly of a Diagnostic X Ray Syste 11 05 2008 04 20 43 f SEEEEEEEEEEEEEEEEEEEEEE EE EEE EE eee Description of Selected Submission Type CBER eSubmitter Pilot Submission The Food and Drug Administration FDA Center for Biologics Evaluation and Research CBER initiated the CBER eSubmitter Pilot program to enable Industry to voluntarily submit Source Plasma Biologics Licensing Applications BLA electronically The eSubmitter tool enables pilot participants to electronically complete and submit a BLA for Source Plasma to CBER s Office of Blood Research and Review OBRR This is a pilot program designed to gather Industry feedback on the eSubmitter electronic submission initiative and determine if this mechanism is a benefit to both the blood Industry and the FDA For additional information on Cancel Next O Step 1 Select a Submission Type The New Submission Dialog wizard is comprised of two parts The first section top portion of the window requires that you select which Submission Type to create When you click on the Submission Type the bottom portion of the window displays information related to the corresponding submission type as shown in the New Submission Dialog box figure above Next Once you have selected the appropriate Submission Type click Next FDA eSubmitter 27 User Manual v5 1 FDA eSubmitter User Manual v5 1 4 Subsection 2 3 Creat
38. F files CVM currently is running Adobe Acrobat 8 0 so if you are planning on submitting Adobe Acrobat 9 0 files please contact technical support at cvmesubmitter fda hhs gov to ensure you do not use a feature that is unsupported lt is acceptable to use plug ins to assist in the creation of a submission However the review of the submission should not require the use of any plug ins other than any provided by Adobe as part of Acrobat and must be compatible with Adobe Acrobat 5 0 or greater The print area for pages should fit on a sheet of paper that is 8 5 inches by 11 inches You should allow a margin of at least 1 5 inch on the left margin and 1 inch on all other sides to avoid obscuring information if the pages are subsequently printed and bound However for files that contain images of labeling page size should be commensurate with the size of the label being presented You should present the label image in the size as if the labeling was in front of you Pages should be properly oriented For example you should set the page orientation of landscape pages to landscape prior to saving the PDF document in final form to ensure correct page presentation Landscape pages including tables should be oriented such that the header and footer of the document align with the right edge of the page PDF viewing software automatically substitutes a font to display text if the font used to create the text is unavailable on the reviewer s computer
39. FDA eSubmitter User Manual Ey neo U S Food and Drug Administration EDA Protecting and Promoting Your Health ie U S Department of Health amp Human Services Document Version 5 1 February 5 2012 DOCUMENT HISTORY Version Number Date Description Official OIVD Pilot Release Software v1 00 01 Version 2 0 March 15 2005 Updated to reflect enhancements incorporated into the CeSub Pilot Release software version 1 10 Updated for applicability to OIVD and Radiological Health Version 3 0 June 24 2005 Updated for corrections and additional descriptions Also updated to reflect the enhancements in Software versions 1 02 00 and 1 03 00 Version 4 0 October 31 2005 Updated to reflect the enhancements in software versions 1 04 00 through 1 07 00 Updated the instructions in the Packaging Submission Files section to incorporate the new packaging feature Updated the instructions for release 1 28 01 to include link to special instructions for Windows Vista Users Updated User Manual to accommodate eSubmitter as an FDA tool and not solely for the use of CDRH submissions Updated to include revised links to the new eSubmitter website on FDA gov gt For Industry 2009 Tobacco Products needs Version 4 8 December 8 Updated to include information regarding CBER OBRR 2010 Pilot Evaluation Program for Blood Establishments That Collect Whole Blood and Blood Components Version 4 9 March 3 2011 Updated to include an app
40. Font substitution can affect a document s appearance and structure and in some cases it can affect the information conveyed by a document We cannot guarantee the availability of any one font Therefore you should embed all fonts you are using in the PDF files to ensure that those fonts will always be available to the reviewer When embedding fonts all characters for the font should be embedded not just a subset of the fonts being used in 110 Page Numbering File Size Document Properties Description Tab Document Properties Initial View Tab FDA eSubmitter User Manual v5 1 the document One problem associated with embedding fonts is that embedding requires additional computer storage space Three techniques to help limit the storage space taken by embedding fonts e limit the number of fonts used in each document e use only True Type or Adobe Type 1 fonts e avoid customized fonts Resizing a document because the contents are too small to read is inefficient We believe that Arial 11 point font is adequate in size for reading narrative text This is the preferred font Although sometimes tempting for use in tables and charts fonts smaller than 11 points should be avoided whenever possible We recommend the use of a black font color Blue font may be used or hypertext links If a font color other than black is used avoid light colors that do not view well on computer screens or do not print well on grayscale printe
41. For photographs the image should be obtained with a resolution of 600 dpi If black and white photos are submitted consider 8 bit gray scale images If color photos are submitted consider 24 bit RGB Color Model images A captured image should not be subjected to non uniform scaling 1 e sizing Files with scanned images and photographs tend to be large in file size Please do not exceed 50MB for a single file Consider multiple files for these types of documents Note Scanned tables and graphs cannot be extracted easily if scanned Most OCR programs will distort the data in tables and graphs Convert MS Word documents to PDF as this method usually retains the formatting For a paper document with handwritten notes Paper documents containing handwritten notes should be scanned at 300 dpi These handwritten notes should be made in black ink for FDA eSubmitter 106 User Manual v5 1 clarity If you have questions about creating electronic copies please contact technical support at esubmitter fda hhs gov to ensure that the format is acceptable prior to developing your submission Naming We are recommending names for folders and selected files in individual PDF Files guidances for specific submission types For uniformity we hope that you use our specific naming conventions when they are provided Reviewers are trained to look for these folders and files and using the recommended names should help avoid misunderstandings improve
42. Information about the FDA Electronic Submissions Gateway can be found at waw fda gov esg Please contact the Gateway Helpdesk with your questions about that system Electronic submissions on CD should be mailed directly to the Document Control Center at Electronic Product Document Control HFZ 309 Attn CeSub Team Center for Devices and Radiological Health 2094 Gaither Road Rockville MD 20850 submissions received in the mail on CD will be processed within a few days of receipt 35 Expert View Outline Area Splitter Bar FDA eSubmitter Subsection 3 1 Application Window The expert view allows the user to navigate through the form using an outline tree located on the left side of the screen The expert view separates the Submission Display Screen into four additional areas as shown below Header Area located at the top Outline Area located at the left Screen Area located to the right Splitter Bar located between the outline and screen areas SE KER Header alala 310 91910 12 19 0 8 2 wi Submission Name Sample Supplement Submission Last Modified Report Type Radiation Emitting Product OMB No 0910 0025 Date Packaged ae Outline Screen Submission Information 3 Product Data What Type of Submission is this Supplements should be submitted selecting the same document type as the original eRadHealthMenu D Manufacturer Da
43. J eSub J Lenovo J Common Files CI FDA CI Messenger C ComPlus Applications J HelpBreeze HTML CI Microsoft J CONEXANT Ci internet Explorer CI Microsoft Acti OOO File Name Files of Type Program Executable Files Select Cancel Finding Word s Executable File Navigation 2 FDA eSubmitter 87 User Manual v5 1 Subsection 4 4 Completing a Submission KJ Select HTML Viewer Application File x Look In E Microsoft Office z Igal e a Bae EJ CLIPART C MEDIA EJ OFFICE11 CJ Stationery Ci Templates Ci visio Viewer File Name Files of Type Program Executable Files v Finding Word s Executable File Navigation 3 Select HTML Viewer Application File Lookin C OFFICE11 coal g a Bale CI XLATORS C MSACCESS EXE MSTORE EXE PROFLWIZ EXE CI XLSTART C MSE7 EXE 7 OIS EXE SELFCERT EXE DSSM EXE C MSOHTMED EXE OSA EXE SETLANG EXE EXCEL EXE MSPUB EXE OUTLOOK EXE UNBIND EXE FINDER EXE MSQRY32 EXE POWERPNT EXE _ WAVTOASF EXE GRAPHEXE mstorpe exe PPTVIEW EXE 7 WINWORD EXE al File Name wl NVWORD EXE Files of Type Program Executable Files v Select Cancel Finding Word s Executable File Navigation 4 4 Click Select You return to the Report Output Dialog Select box with your selection showing as shown below Report Output E Report Output Dialog D
44. List Dialog box Displays the Edit Address Dialog box which allows the selected establishment information to be changed You enter information in this dialog box in the same manner as the New Establishment Dialog box Deletes the selected address from the list Closes the dialog box Displays the help window with text 45 Tools Contact Book Displays the New Edit Delete Close Help FDA eSubmitter User Manual v5 1 Subsection 3 4 Menu Bar Tools Function Contact List Dialog s 2 2 20 s i i CONtactName o o o o Occupation Title box which allows Lucas Laura PresideniCEO Smith John vice President the names and addresses of the pertinent people associated with the report to be maintained You only need to enter each person s name and contact information once into the Contact Book and then you can select the appropriate individual in response to each question Existing addresses can be selected from the Address Book for each contact The Contact Book will be retained and accessible for future reports and you can update it as needed This should reduce confusing misspelled and redundant entries The Contact List Dialog box contains a list of all the available contacts and a comments area for viewing the comments for each selected contact In addition if you scroll across the contact list you will see fields con
45. Package File Name zip text box identifies the default zip file name for the submission eSubmitter automatically uses the submission name for the zip file Make a note of the name for the zip file 2 Specify the submission output location 1 The Package Output Location identifies the file folder where the zip file is located Make a note of the output location ii To change the location click the file folder icon as shown below locate the desired location and click Select Select FDA eSubmitter 91 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Step 2 File Attachment Verification FDA eSubmitter User Manual v5 1 Specify the Submission Package File m Package Output Location C Program FilesieSubiGutputt Le Package File Mame ip n testing zip 2 3 Click Next to proceed to Step 2 File Attachment Next Verification Packaging Files Dialog Packaging Files for Submission Step2 File Attachment Verification File Attachment List File Name File Title Question Count File submission pdt MDUFMA 1 01 04 2008 04 Cancel Previous Next This section lists all file attachments used in the submission 92 Subsection 4 5 Completing a Submission Packaging Submission Files Action Graphic 1
46. Section 5 provides information about the Output menu on the menu bar which includes reports and forms Section 6 provides information regarding user support Please note that the screens used in this document are examples of what you might see while using the software However they may not appear exactly as shown Note The terms submission report and submission report are used interchangeably in this guide to refer to a submission report System Requirements Uninstall Instructions Installation Instructions Installation Instructions from Web Page FDA eSubmitter User Manual v5 1 Subsection 1 3 Software Installation Windows Operating System Adobe Acrobat Reader v5 0 or greater 30 MB of disk space Access to a Compact Disk Recordable drive CD R Drive Software capable of viewing Rich Text such as a Web browser Microsoft Word or Adobe Acrobat full install version not the Reader Before installing eSubmitter uninstall any other version of the software Note If you have a previous version of eSubmitter be sure to save your data files and output files before uninstalling If you do not have a previous version of eSubmitter proceed to installing the current version of eSubmitter software To uninstall a previous version of eSubmitter follow the instructions below Action Graphic 1 Use Windows Explorer to navigate to the location of O esub the eSub file folder on the workstation 2 Delete the eSu
47. a in lets v a eet The parent child relationship can also be seen when in expert view As mentioned on page 36 the expert view allows the user to navigate through the form using an outline tree located on the left side of the screen As seen below the Brand Logo and Registered Trademark is a subfolder to the List of Tobacco Products By Brands folder The subfolder is the child Expert View ome Relationship Product Listing 905 _ List of Tobacco Products By Brands Brand Logo and Registered Trademark El Sub Brand Details Packaging Level Sub Brand Logo SuUb Brand Packaging Information Labeling Staternents Advertising Information Consumer Product Information Establishment Relationship El Components Manufactured by Third Party FDA eSubmitter 8 1 User Manual v5 1 FDA eSubmitter User Manual v5 1 Subsection 4 3 Relationships Across Screens Relationship Example Parent Header As you enter information into the parent and child screens the user will use the List view and the headers to understand the relationship between the data Changing the parent screens will cause the child screens to change Please see below for an example In the expert view on the left you see the parent folder named List of Tobacco Products By Brands below and the parent folder s corresponding simple screen Outline Sereen List of Tobacco Products By Brands Product Listing 205
48. a T Se pea ine prang Stnd mpi Sunn Gark Gdg wich Sg Ee ascona ree we at Bpi for 3 a ihe Fii sore 4 cof Pe eS medi Goad ie iri iie piia Prepon eb ae nar mason ough the s ash a pence proci Thee ter oO con be launched trom fhe come abut drg Pies R P the 7 ini ae ON e T Contact Ur Pea x esho r DORE iti Nncemng His soine appl ation fo Fe eSubmiiter team at Pa Piega be nchi four ame pam A contact niomat Ama emai Cetetretie for Regua Sion torimi appropr ate Office See Contactideresses to fines dated Apphsatec updates panis bo is SOE ate aunt Thee paea wl Gotur Gs Sab E you Ae bgd ono me memel aithe ome that the upptar is launch Primary Thane you again for Wit SURE Ofer Wie look reai fo Reining from you soon Screen Area Function Description Create New Submission Allows you to create a new submission entry The New Submission Dialog box will appear See section Creating a New Submission for more detailed information Open an Existing Submission eSubmitter Quick Guide lt Allows you to open an existing submission The Open Existing Submission Dialog box will appear See section Subsection 2 5 Re open an Existing Submission for more detailed information Launches the eSubmitter Quick Guide If the Quick Guide does not contain the information you are searching for see the full length eSubmitter User Manual Exit Application oi FDA eSubmitte
49. ade available as needed default 64MB The maximum settings should not exceed 1 3 ofthe workstation s available memory For typical submissions the default settings are more then adequate However on rare occasions additional memory may be necessary to handle large amounts of data during entry andlor packaging Enable custom memory settings Minimum memory allocated MB Maximum memory allocated WB Previous Cancel To enable this function do the following FDA eSubmitter IA User Manual v5 1 FDA eSubmitter User Manual v5 1 Subsection 2 2 Setting User Preferences Action Graphic Check the box on the right to enable custom memory a settings To change the minimum memory allocated use the arrows to the right to increase or decrease or by entering a number in the field To change the maximum memory allocated use the arrows to the right to increase or decrease or by __ bar entering a number in the field Click OK OK 25 Introduction Create a New Submission FDA eSubmitter User Manual v5 1 Subsection 2 3 Creating a New Submission This section provides an overview of creating a new submission report Note Before proceeding make sure you have already reviewed the Introduction Getting Started and Interface sections of this user manual These sections provide valuable information that is necessary in order to follow and understand the instructions in this section There are two
50. an be created for the heading of a section subsection or title of figures and tables within the document In general including a bookmark to the main table of contents for a submission or item is helpful Make the bookmark hierarchy identical to the table of contents Use hyperlinks within the file Hyperlinks are used to improve navigation through PDF documents and are encouraged Hyperlinks can be designated by rectangles using thin lines or by blue text or you can use invisible rectangles for hypertext links in a table of contents to avoid obscuring text Hyperlinks throughout the body of the document to supporting annotations related sections references appendices tables or figures that are not located on the same page are helpful and improve navigation efficiency When creating bookmarks and hyperlinks the magnification setting should be set to Inherit Zoom so that the destination page displays at the same magnification level that the reviewer is using for the rest of the document Important Note Hyperlinks between individual PDF document files are not currently supported and any absolute links that reference across files will not work In general for documents with a table of contents provide bookmarks and hypertext links for each item listed in the table of 112 Optical Character Recognition FDA eSubmitter User Manual v5 1 contents including all tables figures publications other references and appendices These
51. ance for Industry FDA Staff and 2 Guidance Documents in the selected list Clear Filter Select Delete OK Cancel FDA eSubmitter 65 User Manual v5 1 Subsection 4 2 4 Question Types Guidance Documents 2 On this dialog box you have several options for searching for a particular guidance document e In the Title text box you can type the title of the desired document if you know what it is e If you do not know the title of the document select the applicable office from the Office list box e On the Division list box select the desired division e Click Clear Filter to delete your selections and Clear Fitter begin a new search 3 Depending on which method you used one or more guidance documents will appear in the Guidance Documents matching the specified filter criteria area of the screen 4 Use the scroll bar to see information about the found guidance documents 5 Ifyou are connected to the Internet and have Adobe View Guidance Acrobat installed click to select a desired document and click View Guidance to see the selection 6 To move a guidance document to Guidance Documents currently selected area of the screen e Click to select highlight a particular guidance document e Click Select The selected document appears in Select Guidance Documents currently selected area of the screen e Repeat the above two items for each desired guidance document e C
52. annan aa a a a a a a a a a T 34 Subsection 3 1 Application Window sseceaiss aie R sn eeeniatandonaus 35 SUSE CHOND 2 OCU A oei e E a Marmerateiinede 40 SUBS Menu Bar OUMUT erse a T aeii 42 Subsection oA Menu Bar Toi kiiesseen a E a 43 Section 4 Preparing a Submission sssseececccccccccccccssssssscccecceccccccccosssssssscecccceceeeosesossssssse 50 CONTENTS saient a NE S 50 Subsection 4 1 Entering Submission Information esssssssoeeerssssssoeerssssssssseeressssssseeees 51 Subsection 4 2 1 Question Types Address and Contact Information eee 53 Subsection 4 2 2 Question Types Option Lists esseseeeeeesssssssseeresssssssseeersssssssseerees 56 Subsection 4 2 3 Question Types File Attachments cccccccccccccccesseseseeeeeeeeeeaeeeees 59 Subsection 4 2 4 Question Types Guidance Documents cccccseseeseeeeeeeeeeeeeeeeees 65 Subsection 4 2 5 Question Types Text Fields and Messages cccceeesseeceeeeeeeeeeeeees 68 Subsection 4 2 6 Question Types Product Codes cccssssssscccceccceeeseseeeeeeeeeneeeeees 70 Subsection 4 2 7 Question Types Standards ccccccccccccsssssesseeeceeceeeaeeesesceeeeeseaeeeeees 76 Subsection 4 2 8 Question Types Sections as Tables 20 0 cccccccccccccssssseeseeeeeeeeeeeeeeeees 78 Subsection 4 3 Relationship Across Screens scccccccccsecssssseeccecessaeeesseeeceeeseaeeesees 81 Subsection 4 4 S
53. anual v5 1 Subsection 4 2 6 Question Types Product Codes Product This question type allows you to search for and then identify Code the product code that is assigned to your product or device If Single applicable you are able to search for the device class device panel and particular CFR section The response to this question is for a single product code Below is an example of a product code question Note The Product Code is specific to those filing with the Center for Devices and Radiological Health Choose the product code for this submission Product Code Mame C F R Section Add any other product codes that are applicable to this submission Enter a Three To enter a three letter code in the product code question follow the instructions Letter Codein below the Product ode Question e If you know the three letter code assigned to your product device enter it in the text field The remaining fields are automatically filled in for you e If you wish to remove your entry click the delete icon e If you do not know the three letter code see the instructions below to search for the code e If you are selecting a product code for a radiation emitting product and do not see an appropriate code enter RZZ Search for a To search for a three letter code by keyword follow the instructions below Three Letter Code by Keyword Action Graphic 1 Click the Select Item icon A Product Code Filter ch Dialog
54. ar in Step 3 Packaging Files Dialog Jeg Packaging Files for Submission l Step 3 Transmission Approach Submittal Letter Package Creation Select Transmission Approach 9 Transmission Approach Send submission in the mail on a CD D Send submission electronically through the Gateway Output Submittal Letter Submittal Letter f View Print Submittal Letter Attach Signed Submittal Letter amp J Produce Submission Package y Package Submission Files L 0 a _Previous Next _Cancel_ FDA eSubmitter 94 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Select Choose the selected approach to send your submission to FDA Transition Approach may gt The first approach is the traditional CD and signed cover letter or may not be mailed to FDA See below for an example applicable Select Transmission Approach Y Transmission Approach i Send submission electronically through the Gateway gt The second approach is only to be used when sending your submission through the FDA Electronic Submission Gateway ESG NOTE If you plan to send your submission through the ESG you will need to register to use the ESG and set up an account Please see FDA ESG for more information regarding the ESG In addition if the Attach Signed Submittal Letter is available you must have the capability to scan your signed cover letter in the subsequent Output Submittal Letter step
55. ater 3 Click Next to continue the registration process Or Next click Register Later to register at another time If SO you click Next you will see a Registration Dialog box Register Later asking you to enter your contact information FDA eSubmitter 8 User Manual v5 1 Subsection 2 1 Starting the Software Registration Registration Dialog Dialog Box eSubmitter Registration Contact step1 Enter Contact Information Information caas Title Mr Ms Dr FirstGiven Name Middle Name Last Name Occupation Title Email Address Register Later Previous Next 4 On the Registration Dialog box enter the information Next requested Required entries are indicated by blue dots Click Next You see a Registration Dialog box asking you to enter address information Registration Registration Dialog Dialog Box eSubmitter Registration Addr ess O Step2 Enter Address Information Information porem Establishment Name Country United States of America Other select below Address Line 1 Address Line 2 City State Province or Territory Post Office or Zip Code Phone Numbers Telephone number Register Later Previous Next 5 On the Address Inform
56. ation dialog box enter the Next information requested Click Next You see a Registration Dialog box to generate an email FDA eSubmitter 9 User Manual v5 1 Subsection 2 1 Starting the Software Registration Registration Dialog Dialog Box eSubmitter Registration Generate Email Stepa Generate Email You provided the following information John Smith john smith sample com Sample Sample Rockville MD 20850 US 301 111 2222 Please verify the information and select the link below to generate an email to send to FDA Generate Email Note We will attempt to generate the email using your local email application After the email is generated and your email software is loaded send it as you would any other email Register Later Previous Next 6 Inthe Generate Email step you see a summary of the Next information you entered If the information is correct click Next If the information 1s not correct click Previous until you return to the screen that you need to correct Previous 7 Click Generate Email in the dialog box You will see an email 8 Click Send in the email You see a Registration Dialog box to check results FDA eSubmitter 10 User Manual v5 1 Subsection 2 1 Starting the Software Registration Registration Dialog Dialog Box eSubmitter Registration Check Results Step Check Results Was the registration email sent successfully Yes the Email wa
57. aving Submission Entries or Changes ccccccccccccceessseeseeeeeeeeeeaeeeees 84 Subsection 4 4 Completing a SUDMISSION cc cseesesecccecccceaeseeeeeeeeecsaeeeseeeeeeeeeeaeeeenees 85 Subsection 4 5 Completing a Submission Packaging Submission Files 0008 90 Section 5 FDA Recommended PDF File Specifications sssssssssccccccssssssscsees 102 SECON 6 USER SUD PORE sresti e deere 108 PS CTU Gas Ales satadstes celeste tabecus ds lasauascansiesselesausetatscchcctessnscesOshessclessesecatsccnestesassecatenensciesees 109 CVM Recommended File SpeciticatiOns scrascivalsstidesciadsasaiicewcdiiaimaliceestiadsacee un 109 FDA eSubmitter ll User Manual v5 1 FDA eSubmitter User Manual v5 1 This page left intentionally blank 111 Section 1 Introduction Contents This section contains the following topics a aa System Background About this Manual 3 Software Installation FDA eSubmitter 1 User Manual v5 1 Subsection 1 1 System Background Introduction The Food and Drug Administration FDA eSubmitter tool is a program that allows participants to electronically complete and submit information for various products to participating Centers This tool is intended to automate the current paper submission process allowing for quicker completion once users are accustomed to the software as well as speed up the filing process with FDA The eSubmitter software requires completin
58. b file folder by right clicking and selecting Delete 3 When the previous version has been uninstalled you are ready to install the current version of the eSubmitter software See the following procedure The eSubmitter software can be loaded from the internet or from a CD ROM The following two subsections will discuss instructions for each The eSubmitter software is available for downloading from the web at FDA eSubmitter To install the latest version of the eSubmitter software from this web page follow the instructions below Installation Instructions for Microsoft Vista Users FDA eSubmitter User Manual v5 1 Subsection 1 3 Software Installation Action Graphic 1 Click the link for downloading the eSubmitter Software and save the jinstall zip file to your computer Download eSubmitter Software 2 Unzip the jinstall exe file and double click on the file to run the eSubmitter installation 3 Follow the instructions provided Following the instructions the software will be installed locally on your hard drive in C Program Files eSub Notes 1 You can change the location where the software is installed by changing the file path on the Installation Directory dialog box when it appears 2 The software may be installed on a network eSubmitter has a file locking option that you set to prevent users from accidentally overwriting the work of another For details see Networking on page 18 Compatibility i
59. copy an existing submission in order to create a new submission follow the Existing instructions below Submission to Create a New Submission Action Graphic 1 Click File gt Open Or click the Open icon on the gJ Tool Bar The Open Submission Dialog box 1s displayed as shown below Open Report E Open Submission Dialog Data Dialog Open Existing Submission Box Select a Submission to Open Submission Name File Name Last Sample Submission Sample Submission xml 01 1 4 2009 04 View the Description of the Selected Submission Create New Submission Cancel 2 Click to select the existing submission report to be Open used as a template and click Open The submission report is displayed on your computer 3 Click File gt Save As The Save Submission As Dialog box is displayed as shown below FDA eSubmitter 30 User Manual v5 1 Subsection 2 4 Copy an Existing Submission to Create a New Submission Save K Save As Submission Dialog Submission As Create New Submission From Loaded Submission Dialog Box Specify the Submission Descriptive and File Names Descriptive Name C e File Name xml e Additional Comments about this Submission Cancel 4 Complete the fields on this dialog box as follows e Descriptive name Enter any descriptive name as long as it is unique to the submission list Use a name that distinctly identifies the report to you Re
60. d into the question Information in the Contact and Address Books requires that you only enter the data once and reuse it across multiple submissions You can also copy information from the question into the Contact or Address Books if you have already begun filling in the question fields directly The figure below shows an example of a multi part contact question Contact Identification Establishment Identification Physical Location Mailing Location lt Tabs Contact Title Mr Ms Dr FirstGiven Name 9 Middle Name Last Name 2 Occupation Title m Email Address 9 Copy To copy information from the Contact Book into the Contact question type Information follow the instructions below from Contact Book into Question Action Graphic 1 Click the Copy from Contact Book icon in the Sl question The Contact List Dialog box is displayed as shown below FDA eSubmitter 54 User Manual v5 1 Subsection 4 2 1 Question Types Address and Contact Information Contact List Contact List Dialog Dialog Box Select a contact Contact Name Occupation Title Lavelle Don Sinkavitch Hope Velezis Marti View comments on the selected contact Select Close 2 Click to highlight and select the desired contact 3 Click Select The contact information is automatically Select populated in the different entry areas within each applicable
61. d like to e enter a new parent e g product category and brand OR e enter a new child to the parent e g the sub brand OR 82 Subsection 4 3 Relationships Across Screens Navigational e continue on to the next section Screen Outline Screen Advertising Information Product Listing 905 Brand Cigarette Marlboro Lights 100 s ea List of Tobacco Products By Brands Sub Brand Marlboro Lights 100 s A GA Sub Brand Details Packaging Level A QA Sub Brand Packaging Information Advertising Information 2 Labeling Statements 2 Advertising Information 2 Consumer Product Information Establishment Relationship am a T a ar ea RR ape ae El 2 Components Manufactured by Third Party gt Data Entry has been completed for the current Sub Brand Select an appropriate option wae below i e adding another or continuing to the next section Select a navigation option Add another Brand Add another Sub Brand Continue to the next section ok Cancel FDA eSubmitter 83 User Manual v5 1 Subsection 4 4 Saving Submission Entries or Changes Introduction FDA eSubmitter User Manual v5 1 While moving through the submission any changes made to question responses are automatically updated within memory e g the user made a change to a question response went to another section of the submission and returned to see that
62. d suitable for inspection review and copying Therefore documents submitted in electronic format should e Enable the user to easily view a clear and legible copy of the information e Enable the user to print each document page by page as it would have been provided in paper maintaining fonts special orientations table formats and page numbers e Include a well structured table of contents and allow the user to navigate easily through the submission e Allow the user to copy text and images electronically into common word processing documents To achieve the above goals you should submit all electronic documents in Portable Document Format PDF PDF is an open published format created by Adobe Systems Incorporated http www adobe com You do not need to use a product from Adobe or from any specific company to produce your PDF documents PDF has been accepted as a standard for providing documents in electronic format by the International Conference on Harmonization ICH Recommended The following recommendations will help you create PDF files with the PDF File appropriate specifications to ensure that we can review and archive the Specifications electronic file attachments FDA eSubmitter 102 User Manual v5 1 PDF Area Version Plug Ins Page Size and Margins Page Orientation Fonts FDA eSubmitter Recommended PDF Specification The PDF files must be compatible with Adobe Acrobat 5 0 or greater without the
63. e ability to switch back and forth between the outline or screen view EEk SE File Edit View Output Tools Help _ aa a F qf r F E Tf i Jf a al F i aa ant 3 teal OD O O 2 2 BB o Submission Name Sample Supplement Submission Report Type Radiation Emitting Product OMB No 0910 0025 Screen View Mz Last Modified Date Packaged fa turer Data Introduction Header Area Electronic Product Radiation Safety Reporting Form This software application is intended to automate the hard copy product reporting forms in the effort of the Center for Devices and Radiological Health CDRH to become capable of accepting electronic submissions from industry and to improve our review process This CDRH Electronic Submission CeSub software is the next version of the application the CDRH is developing to allow us to accept all Radiological Health reports and other submissions electronically and improve the ability of CDRH to accomplish its mandated product and industry evaluations in a timely and efficient manner All electronic reports and correspondence can either be transferred to CD and mailed to the address below or can be sent via the FDA Electronic Submissions Gateway to CDRH If you follow instructions to set up an account with the FDA Gateway when you submit through it you will receive your acknowledgement email message with Accession Number within minutes
64. e dialog box Click the Attach Selected File button to properly attach the selected file to the question response FDA eSubmitter 61 User Manual v5 1 Subsection 4 2 3 Question Types File Attachments Select a New File from the Workstation or Network FDA eSubmitter User Manual v5 1 5 Step 2 Select the File to Attach According to the Method Chosen Select a New File from the Workstation or Network If the file cannot be located in the master list then the method chosen in Step 1 must be Select a New File from the Workstation or Network 6 Step 2 of the File Attachment dialog changes to correspond with the method chosen as shown below K File Attachment Dialog Attach File to Response Step 1 Select the Method for Identifying the File to Attach O Select a File from a List of Previously Attached Files Select a New File from the Workstation or Network Step 2 Locate the File to Attach Locate File 3 4 Descriptive Title e Language General Description ofthe Selected Files Close w Changes Attach Selected File 7 Click the file folder icon to the right of the Locate File field E You will see a Select File dialog box as shown below 62 Subsection 4 2 3 Question Types File Attachments Select File SEI x Look In Gesu z al E al mA Dialog Box File Hame Files of Type Adobe Acrobat Files pdt a
65. e email please be sure to provide the company name and contact information where a response can be sent For CVM related technical support or general inquiries please contact cvmesubmitter fda hhs gov For CBER related technical support or general inquires please contact CBER_eSubmitter_program fda hhs gov 108 Appendix CVM Recommended File Specifications Introduction Regulations in 21 CFR Part 11 require that the Agency be able to generate from any document provided in electronic format an accurate and complete paper copy that is both legible Human readable and suitable for inspection review and copying Therefore documents submitted in electronic format should e Enable the user to easily view a clear and legible copy of the information e Enable the user to print each document page by page as it would have been provided in paper maintaining fonts special orientations table formats and page numbers e Include a well structured table of contents and allow the user to navigate easily through the submission e Allow the user to copy text and images electronically into common word processing documents To achieve the above goals you should submit all electronic documents that don t include data needed for further processing in Portable Document Format PDF PDF is an open published format created by Adobe Systems Incorporated and accepted as an ISO standard under ISO 32000 http Awww adobe com You do not need t
66. endix to reflect CVM specific file specifications Version 5 0 July 26 2011 Updated for production release of CBER BLA BLS submissions for Establishments that Collect Whole Blood and Blood Components including Source Plasma Version 5 1 February 5 2012 Updated to include production release of CDER ICSR submission Updated to include enhancements to the Packaging dialog where very large submissions may be broken into smaller packaged zip files FDA eSubmitter l User Manual v5 1 FDA eSubmitter Table of Contents SCHON Ee TAC OCU CIO M esssS aaa AEE Ea a aaa 1 ENE 0 ES E AE EE A AAS A EEE T E A A E S E S T E E E i subsection 1 1 System Backo round snesie n Mmdaecen Gees eal ieee 2 Subsection I Z A DOU this Manga ls ssepe AERE 3 SupsccHond 3 Software Insta Wau On ssr E S 4 SECHON 2 Gelling SlALLE irpreni a a aea enaa aa a Ea ETE aaa 7 CO S rece a E ee ea tt ee Ree sete T E 7 S bsec on 2 1 Statins the SOMw are ssc ciseriieeeieiec Acct E a N a 8 Subsection 2 2 Setting User Preferences 20 0 0 ceecccsccccccccceeesseeececcceceaaeesseceeeeeeseaeeesees 14 Subsection 2 3 Creating a New SUDNUSSION siesicsscacersioetencoiaiatavado eter e eaa 26 Subsection 2 4 Copy an Existing Submission to Create a New Submission 30 Subsection 2 5 Re open an Existing SUDMISSION cccseeeeeeeceeceeeceeeeseeeeeeeeeeeaaeeeeees 33 Secon Inter la CE sssrinin aaa E a E aa E Eea Saapa oii 34 CONCA e
67. essages Memory Setting preferences prior to creating a submission will make the process much easier To begin setting preferences click on the File Menu gt Preferences The User Preferences Dialog box will appear as shown below Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to the automation of saving data within a timed interval Enable auto save fa Time interval between saves minutes e o5 Next OK Cancel The subsections below will explain how to set preferences for each category FDA eSubmitter 14 User Manual v5 1 Auto Save FDA eSubmitter User Manual v5 1 Subsection 2 2 Setting User Preferences Allows you to automatically save your report while you work You can also set the interval for how often you want to save your report At default auto save is automatically enabled and set to save files at 10 minute intervals Note The Blue Dot indicates that a response to the question is required Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to the automation of saving data within a timed interval Enable auto save Time interval between saves minutes 107 Next ok Cancel To change the auto save option Action Graphic Check the box to enable the auto save feature 1 e to Ca turn auto save on or clear the checkbox to disabled the auto save feature 1 e to turn a
68. g Box Packaging Files for Submission Step 1 Overview and Package File Information What Submission Packaging Entails After completing the submission and verifying there is no information missing you are ready to package the files for submission It is important to note that the packaging process may differ based on the report to be filed Click the hint option i e lightbulb icon for additional information on each step of the process During the packaging process you will verify all file attachments select your transmission approach may not be available for certain reports and produce a complete submission file The packaging process will result in a single ZIP file per submission The ZIP file generated by eSubmitter should not be altered in any way prior to transmitting to CDRH For detailed instructions on packaging your submission files see the eSubmitter User Manual which can be found at http Awww fda gow cdrh cesub download html or the eSubmitter Help located on the Menu bar within the esubmitter application Specify the Submission Package File e Package File Name zip e ltesting zip Package Output Location CAProgram Files eSub Outputl Cancel Next Step 1 This section contains a brief overview of the packaging process Follow the Overview and instructions below Package File Information Action Graphic 1 Specify the submission package file name gt The
69. g a series of questions in electronic forms and allows attaching documents images and media files when additional information is needed If using the eSubmitter software is not desirable you may continue to complete hard copies of reports and applications though for the reasons stated above electronic submission is strongly encouraged FDA eSubmitter 2 User Manual v5 1 Introduction FDA eSubmitter User Manual v5 1 Subsection 1 2 About this Manual The instructions in this manual provide detailed information for installing the eSubmitter software into a computer with a Microsoft Windows operating system In addition this user guide assumes familiarity with terms associated with using a computer e g clicking and double clicking This manual is organized into seven sections including this one Section 1 provides an introduction and explains the requirements for running eSubmitter software uninstall instructions installation instructions installation instructions for Microsoft Vista users and proxy server instructions Section 2 provides instructions for starting the software setting user preferences and creating or reopening a submission Section 3 provides descriptive information about the eSubmitter software s interface and toolbar Section 4 provides instructions for preparing a submission for completion which includes entering information saving submission entries or changes and packaging submission files
70. hat the desired effects would nat be sufficiently visible This question type requires that you click on the box es to select or clear the check mark s to answer a question Multiple responses can be selected See the example below SUBMISSION REASONS Check all that apply 7 New Product i New Indication Other Specify This question type allows you to select an item from a list of options Below is an example of a list item question C F R Section Identifier Name 56 Subsection 4 2 2 Question Types Option Lists Access the List To access the list of available options follow the instructions below of Available Options Action Graphic 1 Click the Select Item icon A Selection List Dialog cP box is displayed as shown below Selection List K Selection List Dialog Dialog Box Select an item from within the list Identifier Name 000 0000 UNDEFINED 1020 10 TELEVISION RECEIVERS 1020 30 DIAGNOSTIC X RAY SYSTEMS AND THEIR MAJOR COMPONENTS 1020 31 RADIOGRAPHIC EQUIPMENT 1020 32 FLUOROSCOPIC EQUIPMENT 1774 items in the list Select Cancel 2 Click to select highlight the desired option 3 Click the Select button The Selection List Dialog box Select closes and you return to the open submission with the list item question showing your selection as shown below C F R section Identifier h 020 10 mije TELEVISION RECEIVERS 4 If you wi
71. have questions please contact the esubmitter Help Desk at esubmittertifda hhs goy Close FDA eSubmitter 97 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files 3 Click Next to proceed to Step 4 to view the Next transmission instructions related to your m submission Step 4 Transmit This section provides confirmation that the submission files have been Submission Package successfully packaged The submission is ready to be sent to FDA Follow the instructions below Action Graphic 1 Read the instructions provided These instructions may vary depending on the approach selected in Step 3 if the option was applicable See below Transmit Packaging Files Dialog Submission Packaging Files for Submission Package Step 4 Transmit Submission Package Review Submission Package Transmission Instructions Submission Package Created Successfully Follow the transmission instructions outlined below 1 Locate the submission ZIP file on your computer s hard drive The file is stored in the Output folder within the eSubmitter directory default location C Program Files eSub output If you changed the output location navigate to the specified location 2 Copy and burn the ZIP file onto a CD Do not modify the zip file after it is generated by eSubmitter 3 Print and sign the submittal letter 4 Mail the signed submittal letter and CD to the address provided in your submission
72. ht hand corner of the dialog box Your files will now be stored in the new specified location Recommended Location If installed on a Network drive on Vista or Windows XP or earlier The location of your data and output files will be contained within the eSub directory where the application was installed If installed on a Workstation on Windows Vista data and output files should be hosted in the following location C Users Public eSub_Home If installed on a Workstation on Windows XP or earlier data and output files should be hosted in the following location C Documents and 20 Subsection 2 2 Setting User Preferences Settings eSub_Homel 4 If you want to change the settings for networking Next click Next or the File Viewer tab See the description for File Viewer below OR If you are finished and satisfied with your changes click OK to close the User Preferences Dialog box on with your changes saved OR Click Cancel to close the User Preferences Dialog _____ _ box without saving any changes Cancel File Viewer Allows you to identify the application that you will use as your PDF viewer Generally Adobe Acrobat is used as the application for viewing PDFs Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to what applications are used to view attached files Adobe pdt Viewer CAProgram FilesiAdobeiAcrobat 8 DAcrobatAcrobat exe g
73. ialog Box Select the application to be used to view the output Select the shading A The application selected must he capable of viewing HTML output e g a Grayscale browser full version of Adobe Acrobat Microsoft wordi Color Select the font size C Other HTML Viewer ere C Large Font OK Cancel FDA eSubmitter 88 User Manual v5 1 Subsection 4 4 Completing a Submission Select the desired shading of the report click the radio button for either Grayscale or Color Select the desired font size click the radio button for either Small Font or Large Font which is approximately 10 pt When you are finished making selections click OK OK The eSubmitter software generates the report in Rich Text which opens for viewing in the application that you selected The missing data output report will either state that there is no data missing or identify the missing data that must be entered as shown below before the files are packaged for submission 4 missdata html Microsoft Word Bile Edit View Insert Format Tools Table Window Help Adobe SF el Ls B Y v i v es f at 2 Normal Arial Arial z 13 B ZU Final Showing Markup z Show Submission Type Is this a bundled submission e User Fee Payment ID Number Please attach the completed MDUFMA Cover Sh 2 0 Contact Information 8 After you have verified that no data is m
74. iewing the comments on the selected establishment In addition if you scroll across the address list you ll see fields containing basic identifier information about each organization The options New Edit Delete Close and Help in this dialog box are described below New Displays the New Address Dialog box which allows a new FDA eSubmitter 43 User Manual v5 1 Subsection 3 4 Menu Bar Tools organization to be created Below is an example Enter information in the fields to identify a particular organization Organization Identification Physical Location Mailing Location Organization Name Past eee l Division Name soon Reference Numbers FDA Establishment Identifier FEN Central File Number CF N D amp B D U N S Number ane Registration Number 2 j Owner Operator Number I Help Finding Registration and Owner Operator Numbers for Devices Help Finding Blood Establishment Registration Numbers Internet Home Page Address Organization Comments ok Cancel Hep gt Click the Physical Location tab to enter address information for where the organization is physically located See below Be dice Dial es Organization Identification Physical Location Mailing Location United States of America Other select below Address Line 1
75. ile to attach The options are 1 Choose a previously attached file from the master list of previously attached files OR 2 Select a new file from your computer or a network drive that has not been previously attached to 60 Subsection 4 2 3 Question Types File Attachments the submission Note The wizard defaults to the method Select a File from a List of Previously Attached Files if the master file list contains any files to choose from If there are no files in the master file list t will default to the method Select a New File from the Workstation or Network If you would like to navigate to a location on your computer and select a new file click the radio button to change the response in Step 1 to Select a New File from the Workstation or Network 3 Step 2 Select the File to Attach According to the Method Chosen Select a File from a List of Previously Attached Files If the file can be located in the list of previously attached files select highlight the file from the list Select a File Select the File to Attach from the List Y from a List of c Previously List of Previously Attached Files Alaja Attached Files Title Name GuestionCount Date Sample Attachment Sample _Atachment_1 pdf 1 0ang 005 06 21 44 1 file in the list 4 Once a file in the list is highlighted the Attach Selected File button is activated in the bottom right Attach Selected File side of th
76. ing a New Submission Action Graphic Step 2 Provide Submission Details as shown below Create New Submission Step2 Provide Submission Details Specify the Submission Descriptive and File Names Descriptive Name e File Name xml Additional Comments about this Submission Complete the fields on this dialog box as follows e Descriptive name Enter any descriptive name as long as it is unique to the submission list and not blank Use a name that distinctly identifies the report to you Required Entry as indicated by the blue dot e File name Enter a valid name for the submission data Use alphanumeric characters Required Entry as indicated by the blue dot File names should not contain more than 100 characters Do not use symbols when naming the files For example do not use slashes tildes asterisks periods brackets single quotation marks double quotation marks or parentheses e Provide additional comments Enter any additional information about this report Optional Entry 28 FDA eSubmitter User Manual v5 1 5 Subsection 2 3 Creating a New Submission Action Graphic When you are finished entering all information in the OK fields click OK The first screen of your new blank submission report is displayed 29 Subsection 2 4 Copy an Existing Submission to Create a New Submission Copy an To
77. ion For example 38 Screen Area View Splitter Bar Subsection 3 1 Application Window e Green check mark indicates no required information is missing e Blue question mark Jindicates at least one item of required information is missing e No mark indicates that the section does not contain any required questions Displays the questions and responses associated with the selected section in the outline area There is complete flexibility in maneuvering through the screen area However questions should be answered in order Responses to some questions will determine whether further questions are required or even applicable which means they may become disabled Some questions within the screen area may be required in order for the report to be considered complete These questions are designated with a blue dot to the right of the question text A complete list of required information that is currently missing from the report can be accessed by selecting the Identify Missing Data option on the Output menu The splitter bar is the vertical bar between the outline and screens areas in the Expert layout as shown below By dragging the bar with the mouse to the left or right you can control the proportion of the window that is allocated to each of the areas Adjusting this bar may be necessary on smaller monitors in order to improve readability of the text File eit View Output Tasis binip 2 bed TD GD ct ee
78. ions Codes by below Keyword Action Graphic 1 Enter a keyword in Product Code Name to search the database You will be provided a list of product codes from which to choose in the in Product Codes matching the specified filter criteria portion of the dialog box FDA eSubmitter 74 User Manual v5 1 Subsection 4 2 6 Question Types Product Codes FDA eSubmitter User Manual v5 1 To further refine your search if desired e Click the Device Class drop down list and make a selection e Click the Classification Panel drop down list and make a selection e Click the Select Item icon next to the Identifier under C F R Selection and make a selection Clear Filter e Click to remove entries and start the search over again Click to highlight the best match to your Select product device and click Select The product device appears in Product Codes currently selected Repeat steps and 2 to continue to add product codes OR Click Delete to remove a product code from the Delete selection oo Click OK to return to the multiple product codes OK question which shows your selections T9 Subsection 4 2 7 Question Types Standards Standards This question type allows you to select a standard for your submission from the list of recognized standards Below is an example of a standards question Select all standards referenced 0 items in the list Adda Standard T
79. issing from the submission you are ready to package your files for submission FDA eSubmitter User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Packaging After completing the submission and verifying that there is no information Submission missing you are ready to package the files for submission To proceed the Files eSubmitter application should be open and the finished submission displayed on your computer screen Package Files To package files for submission follow the instructions below for Submission Action Graphic 1 Click Output gt Package Files for Submission from the menu bar 2 If data is missing see the warning as shown below Warning Waning Sts A A problem occurred while packaging the submission file Submission files cannot be packaged while data is missing from within the report Please complete the report before trying again For a detailed list of all missing items that require a response selectthe Missing Data Report trom the Output menu Display the Missing Data Report now Yes no 3 If the submission has all required data the Packaging Files Dialog box is displayed as shown below Within the Packaging Files Dialog box you will be prompted to move through a series of steps detailed below FDA eSubmitter 90 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Packaging Files ES Dialo
80. ission Information What Type of Submission is this Supplements should be submitted selecting the same document type as the original report 3 Radiation Safety Report Product Report and Supplements za What Type of Product is this Annual Report about What Type of Correspondence is this What Type of Product is this Radiation Safety Report about Laser Products Includes Projection Systems v What Type of Product is this Variance Request about Primary Report What Laser Light Show Document are you filing Screen Hey Parts of the The different parts of the Primary Work Area are defined as follows Primary Work Area FDA eSubmitter 37 User Manual v5 1 Header Area Outline Area View FDA eSubmitter User Manual v5 1 Subsection 3 1 Application Window Displays the following general information about the open submission e Submission Name the name that you created for the report e Report Type depends on the type selected when creating the submission in the Create New Submission wizard e Last Modified represents the date and time the submission information was last saved to the disk file The date and time are automatically updated after each save e Date Packaged represents the date and time the submission files were generated for transfer to FDA The date and time are automatically set after the files are packaged for submission
81. ize and color To aid in the review of both facsimile and FPL submissions CVM recommends that both a pantone ruler for color verification and a photographic ruler for size verification be included in all photographs of final printer labeling Extensible Markup Language XML Specifications The use of XML file format within the CVM eSubmitter templates have been limited to either the submission of Stability data or other data questions One should verify that when an XML file is created it is not created with proprietary formatting as can occur with many common word processing programs The created XML file at a minimum should be viewable with any of the common web browser When creating XML files to support the answers to stability questions FDA eSubmitter 114 User Manual v5 1 the file should conform to the HL7 standard For more information visit the CVM eSubmitter webpage SAS Transport XPT Specifications SAS Transport files are use to package both SAS programs as well as SAS data Currently CVM does not have specific recommendations on how these files should be constructed Therefore stakeholders are encouraged to contact CVM s Biostatistics Teams HFV 163 and 164 FDA eSubmitter 115 User Manual v5 1
82. les should set the Show field as Initial View Bookmarks Panel and Page If there are no bookmarks set the initial view as Tab Page only Set the Page Layout and Magnification fields to default Document PDF files are stored as original documents and will not be altered from their Properties original form Remove any security settings read only or password protection Security used on the files Files submitted with security settings will not be accepted FDA eSubmitter 104 User Manual v5 1 Indexing PDF Documents Full text indexes are used to help find specific documents and or to search for text within documents When a document or group of documents 1s indexed all words and numbers in the file and all information stored in the Document Information fields are stored in special index files that are functionally accessible using the search tools available in Acrobat Portions of a document that are imaged are not indexed Even if the document only contains images the text in the Document Information fields of the file will be indexed All PDF files should be full text searchable prior to submitting to the FDA Bookmarks and Hypertext Links Bookmarks and hyperlinks should be used to assist the reviewers in navigating through the content of the submission If you used either bookmarks or hypertext links consider the following e Use meaningful bookmarks e g the title of the section name of a study data set or facility
83. lick Delete to remove a guidance document Delete from your Selection FDA eSubmitter 66 User Manual v5 1 Subsection 4 2 4 Question Types Guidance Documents 7 Click OK when you have made your selections OK You return to the guidance document question with your selection appearing Below is an example of a guidance document question containing a response Guidance Please enter all referenced Guidance Documents Document 1 item in the list Containing a Document Title ffi Response Implementation ofthe Inspection by Accredited Persons Program Under The Medical Device User CDA Fee and Modernization Act of 2002 Accreditation Criteria Guidance for Industry FDA Staff and FDA eSubmitter 67 User Manual v5 1 Subsection 4 2 5 Question Types Text Fields and FDA eSubmitter User Manual v5 1 Messages Memo This question type provides an area for you to enter several Multi Line lines of text as shown below Text The question may contain a Rich Text Editor which allows you to format what you type bold underline run spell check or insert a table The tool bar for the Rich Text Editor will appear after you click in the text area to begin typing Text This question type allows you to type in text as a response Below Single shows an example of a text question Line Provide the Accession Mumber of the report tor which this is a supplement o Message This question type provides information to you as y
84. nd Settings eSub_Homel datat g of A The Output Location identifies where files are generated as part of the output e g reports A Output Location C Documents and Settings eSub_Homeloutputt g of The Submission Package Location identifies where the final Submission files are located once Ss packaged Package Location C Documents and SettingsleSub_ Hormetpackage of own 37 _ A The Temporary Location identifies where files are generated in support ofthe outputs This should be on alocal drive when working with a network folder for outputs to limit file conflicts between users Temporary Location C Documents and SettingsteSub_Homeltemp _ iela Previous Next OK Cancel To change the file location for each of the folders 19 Select File Location Box FDA eSubmitter User Manual v5 1 Subsection 2 2 Setting User Preferences Action Graphic Click the Select Location icon right of the text box The Select File Location dialog box will appear Click the Look In box and navigate to the file folder where you would like your files stored Ej Select File Location Look In C eSuh z al aal mA File Hame CAProgram FilesteSub Files of Type All Files a Selecta lmGancela Once you have navigated to the location highlight the Select specific folder and click Select in the bottom rig
85. ndow beginning on page 35 If you want to change the settings for networking Next click Next or the Networking tab See the description for Networking below OR If you are finished and satisfied with your changes click OK to close the User Preferences Dialog box on with your changes saved OR Click Cancel to close the User Preferences Dialog box without saving any changes Cancel 17 Subsection 2 2 Setting User Preferences Networking Allows you to set file locking when using the software on a network The application is primarily designed for use by one user at a time However in an effort to help support those that wish to run the application from a network and to prevent users from accidentally over writing the work of another a simple file locking strategy has been incorporated By enabling file locking a user will be warned if the file that they are attempting to open is currently in use by another user At default eSubmitter opens without file locking Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to the networking of the application A The application is primarily designed for use by one user ata time However in an gt eot to help supportthose that wish to run the application from a network and want to prevent users from accidently overwriting the work of another we have incorporated a simple file locking strategy By enabling file locking a user will
86. nt colors keep formatting simple in tables When extracting a table from the PDF document the use of light or white font color will not allow the transfer of text back into some word processing documents Page If a submission includes more than one document you need not provide Numbering pagination for the entire submission Include page numbers only for individual documents It is easier to navigate though an electronic document if the page numbers for the document and the PDF file are the same To accomplish this the initial page of the paper document should be numbered page 1 File Size An electronic submission can have one or multiple file attachments There is not a limitation of the total size of the submission but each file should be limited to 50MB in file size There are several ways to compress file size including but not limited to performing Optical Character Recognition reducing file size in Adobe and creating logical section breaks If you have questions about file size please contact technical support at esubmitter fda hhs gov to ensure the file size is acceptable Document Document properties are used to search for individual documents and to Properties identify the document when found To modify document properties from the tool bar navigate to File Document Properties a Document In the Document Properties box the Initial View tab can also be found In the Properties Document Options section all PDF fi
87. o add a standard follow the instructions below Action Graphic l Click the Add Standards icon You see the Standards Filter Dialog box as shown below Le KJ Standards Filter Dialog Standard Filter Dialog Box Provide Standards filter criteria keywords e TitleiReference Category Organization Standards matching the specified filter criteria Title and Reference Number Category Organizal M 0 Standards in the filtered list Standards currently selected Title and Reference Number Category Organizal a 0 Standards in the selected list Clear Filter 2 Enter title in Title Reference to search the database FDA eSubmitter 76 User Manual v5 1 FDA eSubmitter User Manual v5 1 Subsection 4 2 7 Question Types Standards To further refine your search if desired e Click the Category drop down list and make a selection e Click the Organization drop down list and make a selection Clear Filter e Click to remove entries and start the search over again Click to highlight the best match to your Select product device and click Select The standard appears in Standards matching the specified filter criteria When you are finished adding standards click OK OK You return to the standards question SO TI Subsection 4 2 8 Question Types Sections as Tables Sections as Entire section
88. o use a product from Adobe or from any specific company to produce your PDF documents PDF has been accepted as a standard for providing documents in electronic format by the Veterinary International Conference on Harmonization VICH For data files CVM recommends that either eXtensible markup language XML file format or SAS XPORT XPT be used The file specifications contained within this manual are recommendations from CVM and over time may evolve to accommodate a changing technology FDA eSubmitter 109 User Manual v5 1 PDF Area Version Plug Ins Page Size and Margins Page Orientation Fonts FDA eSubmitter User Manual v5 1 Portable Document Format PDF Specifications Recommended PDF Specification The PDF files should be created to support the PDF A standard Everything needed to render or print a PDF A file must be contained within the file This includes all visible content like text raster images vector graphics fonts color information and much more It also means that a wide range of external content references are disallowed including audio and video content JavaScript and executable files All embedded fonts must be legally embeddable for unlimited universal rendering The PDF files also must be compatible with Adobe Acrobat 5 0 or greater without the use of additional plug ins other than those provide by Adobe as part of Acrobat We should not need any additional software to read and navigate the PD
89. opy of the report if required to FDA Package Allows you to package files for submission after completing the Files for submission and verifying that there is no information missing Submission For more information on packaging files for submission see Subsection 4 4 Completing a Submission on page 85 42 Subsection 3 4 Menu Bar Tools Introduction Each command on the Tools Menu is described Tools Help below Address Book Contact Book Submission File List Assign Submission ID Tools Function Address Book Displays the S Address is Diales Address List Aa Organization Count Dialog box which Food and TEE US i ETS provides the ability to maintain the addresses of the pertinent manufacturing and corporate facilities associated with your reports You only need to enter each organization name and address once into the Address Book then select the appropriate entry in response to each question If the mailing address is the same as the physical address the physical address can be copied into the mailing address fields If they are similar but not exactly the same it can be copied and then edited The Address Book will always be accessible for future reports and you can update it as needed This should reduce confusing misspelled and redundant entries The Address List Dialog box contains a list of all the available organizations and a comments area for v
90. ou complete a submission You may see several different types of messages as you progress through your submission Different examples of the message types are listed below Information Message Q Selectthe CORH Recognized Standard trom the available list Error Message Subsection 4 2 5 Question Types Text Fields and Messages Unfortunately this software currently only supports submissions for in vitro diagnostic devices radiation emitting products and medical device adverse event reporting For all other submissions please check back at a later date for information on additional submissions that will be supported by this software Please email any questions or comments to the CeSub team at cdrhesubm ecdrhidagoyv Be sure to include your name company name and contact information in the email Thank you again for using our electronic product reporting software Note Message A Contains Information on the Applicable Contacts Confirmation Message D Save the following changes before closing the report template o Warning Message A Any changes made will be lost ifthey are not saved Selecting the Cancel button will preventthe operation from continuing fi e closing the report template Missing Data Message Select an option C would like to add another Product am finished entering Product s and would like to move to the next screen OK Cancel FDA eSubmitter 69 User M
91. quired Entry as indicated by the blue dot e File name Enter a valid name for the submission data Use alphanumeric characters Required Entry as indicated by the blue dot e Provide additional comments Enter any additional information about this report Optional Entry 5 When you are finished entering all information in the OK fields click OK The first screen of your new submission report 1s displayed FDA eSubmitter 31 User Manual v5 1 Subsection 2 4 Copy an Existing Submission to Create a FDA eSubmitter User Manual v5 1 New Submission Since you copied an existing submission it already has many or all questions answered You now have the opportunity to go through and change responses for this new submission Creating a new submission in this manner is convenient if you are creating a supplemental report or creating a report for a product in an existing product family You are now ready to change the responses in this submission go to Entering Submission Information on page 51 32 Subsection 2 5 Re open an Existing Submission Re open an To re open an existing submission follow the instructions below Existing Submission Action Graphic 1 Click File gt Open on the menu bar OR Click 0 on the tool bar The Open Existing Submission Dialog box 1s displayed as shown below Open Existing EJ Open Submission Dialog Submission Open Existing Submission Dialog Box Select
92. r User Manual v5 1 Closes the eSubmitter application 12 Subsection 2 1 Starting the Software z Displays the Help Menu which provides a a d instructional information and support for utilizing the eSubmitter application F This arrow allows you to move forward orward Navigation Arrow through the Message Tabs Backward 4 This arrow allows you to move backwards Navigation Arrow through the Message Tabs ie Ay Allows you to collapse and expand the Menu Options portion of the Intro Screen sig The yellow stars are intended to notify users when new messages are available The star appears next to the message tab header with new unread messages Allows you to filter the message am Fiter Show All information to display only generic information or those messages pertaining to a particular program eSubmitter will remember the selected filter option upon closing and reopening the application This checkbox enables you to indicate which message tabs have been read Mark this checkbox to remove the yellow star shown next to the tab header Unmark this checkbox to make the yellow star on the applicable tab header reappear Collapse Expand Arrows Notification Stars Mark as Read i Mark as Read FDA eSubmitter 13 User Manual v5 1 Subsection 2 2 Setting User Preferences Introduction eSubmitter allows you to set preferences for the following categories Auto Save Layout Networking File Location File Viewer M
93. r requires a user id and password add the following two properties to the update control file that is also located in the J Express subdirectory proxyUserName proxyPassword Section 2 Getting Started Contents This section contains the following topics OCE Starting the Software Setting User Preferences Creating a New Submission Copy an Existing Submission to Create a New Submission Re open an Existing Submission FDA eSubmitter 7 User Manual v5 1 Subsection 2 1 Starting the Software Introduction After you have successfully installed the eSubmitter software you are ready to start up the application and create a new report Starting the To start up the eSubmitter application follow the instructions below Software Action Graphic Start and select Programs gt FDA Submission Software gt eSubmitter 2 You will see a Registration Dialog box as shown below Registration Registration Dialog Dialog Box eSubmitter Registration Overview Why Register Please register this software with the Food and Drug Administration FDA By registering you will be providing valuable statistical data that will be used in an effort to better Understand the needs of industry as well as to help justify and guide future development efforts The registration process entails the entering of general contact information and the generation of an email directed to FDA Select the Next button below to proceed Register L
94. rences and appendices These bookmarks and hypertext links are essential for the efficient navigation through documents FDA eSubmitter 105 User Manual v5 1 Section 5 FDA Recommended PDF File Specifications Optical Character Recognition PDF documents produced by scanning paper documents are usually inferior to those produced from an electronic source document such as MS Word Scanned documents are more difficult to read and do not allow the reviewers to search or copy and paste text for editing The use of scanned documents should be avoided if at all possible If scanning cannot be avoided the following is highly recommended e Perform optical character recognition OCR on all scanned documents so that the text 1s searchable e Check to see that the content has been correctly converted If the source document is only available on paper it should be scanned at resolutions that will ensure the pages are legible both on the computer screen and when printed At the same time remember to limit the file size to be less than SOMB We recommend scanning at a resolution of 300 dots per inch dpi to balance legibility and file size We discourage the use of grayscale or color because of file size After scanning avoid re sampling to a lower resolution For files with images and photographs Also when creating PDF files containing images you should not resample images Re sampling does not preserve all of the pixels in the original
95. rs if printing is necessary It is advised that you test the color reproduction prior to submission by printing sample pages from the document using a grayscale printer In addition to font colors keep formatting simple in tables When extracting a table from the PDF document the use of light or white font color will not allow the transfer of text back into some word processing documents If a submission includes more than one file you need not provide pagination for the entire submission Pagination should occur on an individual attached file basis An electronic submission can have one or multiple file attachments There is not a limitation of the total size of the submission but each file should be limited to 100MB in file size There are several ways to compress file size including but not limited to performing Optical Character Recognition reducing file size in Adobe and creating logical section breaks If you have questions about file size please contact technical support at cvmesubmititer fda hhs gov to ensure the file size is acceptable Document properties are used to search for individual documents and to identify the document when found To modify document properties from the tool bar navigate to File Document Properties In the Document Properties box the Initial View tab can also be found In the Document Options section all PDF files should set the Show field as Bookmarks Panel and Page If there are no bookmarks set
96. s may appear as a table This is referred to as a tabular view follow Tables witha the instructions below Tabbed View The tabbed view format is indicated by a row of buttons for New Delete Delete All an up arrow and a down arrow Directly below this row of buttons is the actual table as shown below List View New Delete Deletean List Details List of Sites Status Change Manufacturer Contract Manufacturer Contract Sterilizer Yes Mo Yes Yes Ma Ma Yes Yes You also see a List and Details tabs Click the New button to add an item to the table You see a screen containing questions for you to answer An example is shown below Details View Delete all List Details Details of Selected Site Status of Change r mal Site Operation Manufacturer w Lx Contract Manufacturer ial Lx Contract Sterilizer a fai To see the items in the table click Details If you accidentally enter a blank into the table by clicking New not responding to any questions and then clicking Details you will see a line of colored blank spaces Select the line of colored spaces and click the Delete button to remove the item from the table Sections as Similar to the tabbed view in the panel view entire sections may appear as a Tables with a table follow the instructions below Panel View This format is indicated by a row of buttons for Add New Delete FDA eSubmitter 78 User Manual v5 1 S
97. s sent successfully O No there was a Problem If not what was the issue Registration completed Select the Done option below to end the registration process Previous 9 Select the button corresponding to either Yes the Email was sent correctly or No there was a problem 10 Click Done if the email was successful and to Done complete the registration process 11 Next you will see the ntro Screen which is described in the subsequent section FDA eSubmitter User Manual v5 1 11 Intro Screen Subsection 2 1 Starting the Software The Intro Screen provides an introduction to the software and will serve as your home screen The ntro Screen will be displayed as shown below and the contents and tools available in the Intro Screen are described in the following table Menu Bar Navigation Tool Bar gt au FA cd oe G Mir Opiera E r M Veto erie ea hiiia Tg Aor Eiaa inks ey dike uestions History O ti Welcome to eSubmitter An FOA Electronic Submissions Software Initatve Bearden Tre ware appir on priate tector submission of reguistory informabon to Aes an enot to automate b Jubain si Pane TE Somana a Gaie TE Gf daia capiuig y bowls Foc nepi Arog Darpa 10 popni delaia PONI I dto a ow FE Ato chet ist Abii Tabs ey sin wreg or al Thee beneti ki Caner a miiia me PEA te merme Ce Piet minia D ra E kangi RAAN iE 7 qamna kaad To ine ur
98. see below Select Transmission Approach Y Transmission Approach O Send submission in the mail on a CD Output Submittal Letter Y Submittal Letter View Print Submittal Letter Attach Signed Submittal Letter J Output Submittal Follow the instructions below for the Output Submittal Letter Letter may or may not be applicable Action Graphic Click the View Print Submittal Letter button as Shown below FDA eSubmitter 95 User Manual v5 1 Subsection 4 5 Completing a Submission Packaging Submission Files Output Submittal Letter Y Submittal Letter View Print Submittal Letter Attach Signed Submittal Letter tJ 2 a Ensure that your submittal letter 1s accurate b Print and sign the submittal letter c Prepare to mail the submittal letter for CD transmission approach OR d Scan the submittal letter for Gateway transmission approach and note the location where you store the file you will need to navigate to this location in the next step 3 Click on the folder icon see below to attach the signed submittal letter that has been scanned Output Submittal Letter Y Submittal Letter View Print Submittal Letter Attach Signed Submittal Letter J 4 Once you have located the signed cover letter click Select Select to attach the file to the packaging dialog box The signed cover letter path should appear as shown below
99. sh to change your response click the delete a icon Your response selection is deleted from the question FDA eSubmitter 57 User Manual v5 1 Subsection 4 2 2 Question Types Option Lists 5 Repeat steps 1 through 3 to make another selection Table This question type allows you to select from a list or add text items that are then placed in a table Below is an example f necessary identify the secondary Classification Panel 0 of 10 items in the list Select multiple To select from a list of options or to enter text responses into a table question options or enter type follow the instructions below text responses into a Table Action Graphic 1 Click the Add icon EJ 2 You will be prompted to either select from a list of options or enter a response into a text field 3 Ifyou wish to change your response select highlight the option in the table and click the delete icon The a selection is deleted from the question list 4 Repeat steps 1 and 2 to make another selection or enter text responses into the table FDA eSubmitter 58 User Manual v5 1 Subsection 4 2 3 Question Types File Attachments File Attachment FDA eSubmitter User Manual v5 1 Please see Section 5 FDA Recommendations for PDF File Specifications to ensure you are meeting the FDA recommendations for electronic files submitted and archived This question type allows you to attach a file as a response The ques
100. ssues have been identified regarding the use of eSubmitter with the Windows Vista operating system These issues related to the installation of the software under the Program Files directory can prevent accessibility to data and output files generated by the software These issues can be averted by relocating the eSubmitter Data and Output folders to a less restrictive directory e g C Users Public eSub_Home These settings can be changed by navigating to the File gt Preferences option within the application If you have already upgraded to the Windows Vista operating system or plan to in the future see Instructions for Using eSubmitter on Vista on the FDA eSubmitter website for the latest information on successfully installing the tool within Windows Vista Proxy Server Instructions FDA eSubmitter User Manual v5 1 Subsection 1 3 Software Installation If you are using a proxy server to connect to the Internet then you will need to change the application s properties file eSubmitter properties to reference the server See your System Administrator for help in changing the properties file The properties file is located in the application s JExpress subdirectory Program Files eSub JExpress Add the following switches before the cp switch DproxySet true DproxyHost proxy_host DproxyPort proxy_port replace proxy_host and proxy_port with the appropriate information for your configuration If the proxy serve
101. ta report 2 Role i 2 Radiation Safety Report Product Report and Supplements mA 2 Submission Information What Type of Product is this Annual Report about What Type of Correspondence is this What Type of Product is this Radiation Safety Report about e Laser Products Includes Projection Systems a Sc ree n What Type of Product is this Variance Request about Area What Laser Light Show Document are you filing 36 User Manual v5 1 Subsection 3 1 Application Window Layouts Both layouts provide the same information It is your choice as to which layout works best for you You can switch between the two layouts very easily as well as customize eSubmitter to open in the expert layout To learn how to change eSubmitter so that the application opens in the expert layout rather than in the simple layout see User Preference Tab Layout on page 16 The Application Window whether in simple or expert layout is divided into three parts as shown below 1 Menu Bar 2 Tool Bar 3 Primary Report Screen EJ eSubmitter PES Menu file Edit View Output Tools Heip Bar Bed B D a O O e 2 2 a Oaa as Too Bar Submission Name Sample Supplement Submission Last Modified 01 21 2009 04 33 21 PM Report Type Radiation Emitting Product OMB No 0910 0025 Date Packaged in Screen View eRadHealth Menu Subm
102. taining basic identifier information about each contact The options provided in this dialog box are described below Displays the New Contact Dialog box which allows a new contact to be created Displays the Edit Contact Dialog box which allows the selected contact information to be changed Deletes the selected contact from the list Closes the dialog box Displays the help window with text 46 Tools Submission File List FDA eSubmitter User Manual v5 1 Function Displays the Master File Attachment Dialog box which allows you to manage the file information to be attached for use across questions in the submission z my S Manage File Attachment List Step1 Select an Option for Managing the File Attachment List 9 O View Manage the List of Files Added Add a New File from the Workstation or Network to the List Step 2 Locate the File to Add F Locate File 9 ESTE oj Descriptive Title Description ofthe Selected File Close w Changes Add Selected File to the List Attaching PDF files requires software capable of viewing and or printing PDF files e g Adobe Acrobat If you did not set your file viewer under User Preferences the first time a PDF file is attached the software will prompt you to locate the application within the system that will be used to view print such files Once identified the software will no longer prompt for this information
103. ther you will receive missing data messages upon leaving a data entry screen Allows you to indicate whether you will receive List Add Navigation messages when leaving list screens x Auto Save Layout Networking File Location File Viewer Messages Memory Preferences related to Messages displayed within the application Enable Wissing Data message when leaving screens during normal navigation lal a T Enable List AddiNavigation message when leaving List screens ra Previous Hext Ol Cancel To enable these functions do the following 23 Subsection 2 2 Setting User Preferences Action Graphic 1 Check the box on the right to enable Missing data r messages To disable this function check the box so that it is 2 clear of any check marks 3 Check the box on the right to enable List F Add Navigation messages To disable this function check the box so that it is m 4 clear of any check marks 5 Click OK OK Memory Allows you to identify how much memory will be allocated when the application starts default 2MB and how much memory will be made available as needed default 64MB Auto Save Layout Networking File Location File Viewer Messages Preferences related to the custom memory settings used by the application A The memory settings identity how much memory willbe allocated when the application starts default 2MB and how much memory willbe m
104. tion may contain a text editor that allows or requires you to type additional information In addition this editor may be a Rich Text Editor which allows you to format what you type bold underline run spell check or insert a table You may use this area to provide descriptive information or clarification such as see page 15 of the attached user manual You may be required to enter the attachment or provide the descriptive text Note that the question itself may be restricted to only allow certain file types to be attached e g PDF only or a combination such as PDF and or Excel file types only Attaching PDF files requires software capable of viewing and or printing PDF files e g Adobe Acrobat The first time a PDF file is attached the software will prompt you to locate the application within the system that will be used to view print such files See below x D Reports require a PDF compatible viewer in order to be displayed and as of yet no 6 viewer or an invalid viewer has been specified Specify a PDF viewer now For example a typical location for the Adobe PDF viewer on a Windows machine is Program Files AdobelAcrobat 4 0 Reader The typical executable file name is AcroRd32 Yes No Once identified the software will no longer prompt for this information For information on setting up your PDF Viewer see page 21 Below is an example of a file attachment question with
105. tion Graphic 1 Click the Add Guidance icon The Guidance Document Filter Dialog box is displayed as shown a below Guidance SY Guidance Document Filter Dialog Document Provide Guidance Document filter criteria keywords Filter Dialog i giis corn Division Box Guidance Documents matching the specified filter criteria Title Office Division Implementation of the Inspection by Accredited Persons Program Under The Medical Device User CDRH httoviwww fda govicd lt Fee and Modernization Act of 2002 Accreditation Criteria Guidance for Industry FDA Staff and Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry CDRH http www fda gowed A and FDA Staff User Fees and Refunds for Premarket Approval Applications Guidance for Industry and FDA Staff CDRH httpviwww fda gowed Expedited Review of Premarket Submissions for Devices Guidance for Industry and FDA Staff CDRH http www fda gowed 8 Guidance Documents in the filtered list Guidance Documents currently selected View Guidance i Office Division itle Draft Guidance Document for 510k Submission of Immunoglobulins 4 G M D and E OlvD DIHD http uiwww fda goved Immunoglobulin System In Vitro Devices Implementation of the Inspection by Accredited Persons Program Under The Medical Device User CDRH httpviwww fda gowed Fee and Modernization Act of 2002 Accreditation Criteria Guid
106. tton becomes enabled Click the Select button You see the Select HTML Viewer Application File dialog box as shown below Select HTML Select HTML Viewer Application File Viewer spain Fle wae SH WE Dialog Box B eSubmitter exe 4 Uninstall exe File Name Files of Type Program Executable Files T E FDA eSubmitter 86 User Manual v5 1 Subsection 4 4 Completing a Submission 3 e Click in the Look In box to navigate to the executable EXE of the application to view the HTML For example if you want to view the missing data output report in Word 2002 you would navigate using the following path C gt Programs gt Microsoft Office gt Microsoft Office gt Office 10 gt WINWORD EXE The following screens display an example for the navigation sequence to find Word 2002 s executable winword exe Kj Select HTML Viewer Application File Look In C eSub z aal A al MRA CI My Documents CI My Computer Local Disk C J Program Files Ci eSub DVD RAM Drive D l Cdrh shr on Fdswf003 Group02 K File Name Files of Type Program Executable Files hs Select Cancel Finding Word s Executable File Navigation 1 J Select HTML Viewer Application File Look In program Files nA al ft ci mA CJ Adobe CI Documentum Ci intervideo CI CeSub_eCopiesTest CI eDesigner_Test cJ IsI J Cisco Systems CI eRoom 7 J Java Cf Citrix
107. ubsection 4 3 Relationships Across Screens Delete All an up arrow and a down arrow Directly below this row of buttons is the actual table as shown below Screen List of Tobacco Products By Brands Parent Reference Name Sample Name List View Parent Sub Reference Name Sample Sub Name Product By Brands i List Detail AddNew Delete Delete Al my amp Table of Brands gt item Product Category Product Category Sub Type Brand Family Name gt 1 Cigarette Marlboro 2 Snuff Coppenhagen The up and down arrow as seen below will allow you to select a specific row when you have multiple entries You can be sure that the appropriate row is selected as the row will be highlighted in blue and there will be an arrow in the right hand column Please note the Item number column as this will be discussed in the List and Detail tab below Screen List of Tobacco Products By Brands List View Parent Reference Name Sample Name Parent Sub Reference Name Sample Sub Name with arrows Product By Brands List Detal Add New Delete pDeetea CS Table of Brands gt _ Item_ Product Category Product Category Sub Type Brand Family Name 1 Cigarette Marlboro gt 2 Snuff Coppenhagen You also see a List and Details tabs Click the New button to add an item to the table You see a screen containing questions for you to answer
108. ugh the form and answering questions If you use the simple layout you progress through the form screen by screen ensuring that you have filled in all appropriate responses If you use the expert layout you progress through the outline sections of the form activate each section to load the section questions and responses and ensure that you have filled in all appropriate responses You may also use the green navigation arrows located in the tool bar to move through the submission in expert view Note For the purpose of this guide all graphics are in the expert view Also information marked with a blue dot is required For additional information on the simple and expert layouts see Interface on page 34 It is strongly recommended that you follow the order of the sections as they are listed in the outline The order has been set up to represent the most logical progression through the submission form This is especially important for first time users who are less familiar with the application to ensure you have filled in all appropriate responses Entering To enter responses into the submission follow the instructions below Responses into the Submission Action Graphic 1 The eSubmitter application must be open on your computer desktop and a submission must be open If the application and a submission are not open see the instructions beginning on page 8 2 Navigate through the submission as follows e If you are in the simple
109. uto save off If you cleared the checkbox go to step 3 If you selected the checkbox in the time interval box Enter the interval in minutes for how often you want to save the file OR Use the up and down arrows to select the interval 15 Subsection 2 2 Setting User Preferences 3 If you want to change or set the layout click Next or Next the Layout tab See the description for Layout below OR If you are finished and satisfied with your changes click OK to close the User Preferences Dialog box om with your changes saved OR Click Cancel to close the User Preferences Dialog box without saving any changes Cancel Layout Allows you to set whether you want eSubmitter to open reports in the simple or expert layout when you start up the application At default eSubmitter opens reports in the simple layout For more information see descriptions in the Application Window section on page 35 E Preferences related to the layout appearance of the application Initial layout at startup Simple Previous Next OK Cancel To change the layout when eSubmitter starts up follow the instructions below FDA eSubmitter 16 User Manual v5 1 FDA eSubmitter User Manual v5 1 Subsection 2 2 Setting User Preferences Action Graphic In the initial layout box select Simple or Expert from the drop down menu For more information on these layout options see Subsection 3 1 Application Wi
110. v avi e Image Files gif tif jpg e Extensible Markup Language Files xml dtd e Archive Compressed Files zip e Standard Generalized Markup Language Files sgml e MDL Molfiles Files mol However CVM submission will only permit PDF XML and or XPT files Based on the question you are answering the question may have restrictions on which file types you are allowed to attach For example some questions may allow you to attach any of the three file types permitted by CVM and some may only allow you to attach PDF and XML files as the questions response or supporting documentation Facsimile and Final Printed Labeling FPL in PDF files Final printed labeling FPL are required to be submitted as part of the animal drug approval submission However in lieu of FPL CVM permits the submission of facsimile labeling with the A NADA as long as the FPL is submitted prior to marketing the approved product In the electronic world facsimile labeling would represent the 2 dimentional aspect of the labeling components including color size and fonts without the labeling actually being produced The PDF files with facsimile labeling need to contain the images graphics of the labeling components without actual pictures of the final printed label components printed on their intended media bag foil pouch syringe etc The PDF files for FPL should contain the actual pictures of the different label component embedded at their actual s
111. y the files onto a CD or transmit via the Electronic Submissions Gateway ESG You will only be able to package files for submission as long as no required data is missing from the submission To determine if any data is missing you will generate a Missing Data Report To proceed the desired submission should be open and displayed on your computer screen Note All report outputs are generated as Rich Text and require an application capable of viewing Rich Text output such as a WEB browser the full version of Adobe Acrobat not Acrobat Reader or Microsoft Word To determine if required data is missing from the submission follow the instructions below Action Graphic 1 From the menu bar click Output gt Missing Data Report The Report Output Dialog box is displayed as shown below Ej Report Output Dialog Select the application to be used to view the output Select the shading A The application selected must be capable of viewing HTML output e g a STs browser fullversion of Adobe Acrobat Microsoft Word Color K Default Browser Select the font size _ Other HTML Viewer Small Font C Large Font 85 Subsection 4 4 Completing a Submission 2 On this dialog box e Select the desired application to view the output in Rich Text e Click the option button Default Browser or Other HTML Viewer The default setting is your Web Browser If you selected Other HTML Select Viewer the Select bu

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