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U.S. Department of Health and Human Services

For Industry

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Frequently Asked Questions on eSubmitter and OIVD

This document contains Frequently Asked Questions (FAQ) received to date from existing FDA eSubmitter users. This FAQ is meant to provide support for those Industry users interested in submitting a Turbo 510(k) electronic submission. For your convenience, the questions are separated into two sections, Administrative Questions (related to an OIVD 510(k)) and Technical Questions (related to the FDA eSubmitter application). If you continue to experience issues or you are not able to find a question that matches your scenario, please contact us.

Administrative

  1. What constitutes a complete 510(k) eSubmission to the Office of In Vitro Diagnostics (OIVD)?
  2. When I submit a 510(k) eSubmission for OIVD using the FDA eSubmitter software, do I need to include hardcopies of the 510(k)?
  3. When I submit an eSubmission do I still need to submit a signed hardcopy of the Truthful and Accuracy Statement, the Declaration of Conformity of complying with the GMPs, or the Indications for Use Statement?
  4. Can digital signatures be used?
  5. Once I package the completed eSubmission, what do I burn to the CD?
  6. How should I answer the questions with the optional file attachment in the FDA eSubmitter application?
  7. How can I check to make sure that all the attached files in the eSubmission are included on the CD?
  8. How many copies of the CD should be sent to the FDA?
  9. What types of submissions/reports can be submitted to the Center for Device Evaluation and Radiological Health (CDRH) using the FDA eSubmitter software?
  10. How do I receive software updates from the FDA?
  11. What if my company has a firewall that prevents automatic updates of software?
  12. How can I store the eSubmissions for record keeping in my company?
  13. Is the FDA eSubmitter software Part 11 Compliant?
  14. Where can I find more information on the appropriate and efficient use of the FDA eSubmitter software (i.e. User Manual, etc)?
  15. Is there a technical support number for questions or troubleshooting?
  16. Whose name and mailing address appears on the Submittal Letter generated by the FDA eSubmitter?
  17. How can I include information on the Secondary Contact in the Submittal Letter generated by the FDA eSubmitter?

Technical

  1. What are the computer and system requirements to run the FDA eSubmitter software?
  2. What are the known compatibility issues with FDA eSubmitter running on a Windows Vista operating system?
  3. I am planning to install FDA eSubmitter on Windows Vista. How do I proceed?
  4. I installed FDA eSubmitter on an earlier version of Windows and I have since upgraded to Windows Vista. What are my potential issues?
  5. How do I "Bundle" 510(k) submissions using the FDA eSubmitter software?
  6. What if a question or section does not apply to my device?
  7. How do I attach files?
  8. What types of files can I attach?
  9. Can I attach SAS XPORT files as a PDF?
  10. Can I cut and paste text into the text boxes in the FDA eSubmitter software?
  11. What if I do not find a relevant section or question for the information that I want to include in the eSubmission?
  12. Can I view an individual submission on multiple computers?
  13. Can an old eSubmission be reused to generate a new eSubmission by editing it to include the new information for a similar device?
  14. What do I do if I "package" the eSubmission and then decide to make a change?
  15. What if I want to make a change to a file after it has been attached to a question in the eSubmission?
  16. Should I set security settings or passwords on my PDF files that are attached to the questions in the eSubmission?
  17. Which PDF versions are supported by the FDA eSubmitter software?
  18. Can I attach pictures or plug-ins to the questions in the eSubmission?
  19. Can I use bookmarks in my PDF attachments?
  20. Can I scan documents and include them as attachments?
  21. How should I name the attached PDF files?
  22. What is the recommended font for the PDF attachments?
  23. What if the standard I want to reference in the eSubmission (section 7.0 of the Admin tab) is not listed in the FDA eSubmitter software database?
  24. What if I get a message that says my file cannot be viewed because it cannot be located?
  25. What does it mean when I get a message indicating that the FDA eSubmitter template will become “inactive?”
  26. What happens if I change the location of the project files after the CD was burned (if I try to open the FDA eSubmitter application for the specific project)?
  27. Does FDA eSubmitter perform an "autosave?"  If it does, can it be turned off?
  28. Once I package the completed submission, what do I burn to the CD?

Administrative

Q1. What constitutes a complete 510(k) eSubmission to the Office of In Vitro Diagnostics (OIVD)?

A complete 510(k) eSubmission for OIVD includes the CD containing only the zip file generated from the FDA eSubmitter software, a printed and signed Submittal Letter generated from the FDA eSubmitter software, and previously paid MDUFMA fees.

Q2. When I submit a 510(k) eSubmission for OIVD using the FDA eSubmitter software, do I need to include hardcopies of the 510(k)?

No, you only need to submit the CD (eSubmission) and a signed Submittal Letter generated from the FDA eSubmitter software.

Q3. When I submit an eSubmission do I still need to submit a signed hardcopy of the Truthful and Accuracy Statement, the Declaration of Conformity of complying with the GMPs, or the Indications for Use Statement?

No, the Submittal Letter generated from the FDA eSubmitter software contains the Truthful and Accuracy Statement, Conformity of complying with the GMPs when applicable, and the Indications for Use Statement.

Q4. Can digital signatures be used?

Not at this time, but in the future the digital signature will be available in conjunction with the FDA Gateway.

Q5. Once I package the completed eSubmission, what do I burn to the CD?

ONLY BURN THE ZIP FILE located in the Output folder to the CD. Do not add any other folders or save any other files to the CD.

Q6. How should I answer the questions with the optional file attachment in the FDA eSubmitter application?

The software is designed to allow you to enter a response in an executive summary format in the text box. The software then allows you to attach a file containing supporting information. The attached files can be study design, clinical protocols, raw data, SAS transportable files, Excel data sheets, etc. It is very important that you answer each question separately because the Reviewing software uses the information in the Executive Summary text box to generate the review memo and the Decision Summary that will be posted on the web page.

Q7. How can I check to make sure that all the attached files in the eSubmission are included on the CD?

The attached files will be listed within the zip file. They can be opened and reviewed. DO NOT ALTER THE ZIP FILE IN ANY WAY when you review the attachments.

Q8. How many copies of the CD should be sent to the FDA?

Only one copy of the CD should be sent to the FDA.

Q9. What types of submissions/reports can be submitted to the Center for Device Evaluation and Radiological Health (CDRH) using the FDA eSubmitter software?

The FDA eSubmitter software currently supports three types of submissions and reports for CDRH.

  • In vitro diagnostic (IVD) premarket notification [510(k)] to OIVD including CLIA Waiver and categorization applications
  • Rad Health Reports, to Office of Communication, Education and Radiation Programs (OCER)
  • Medical Device Report (MDR) (if pilot program participant)

Q10. How do I receive software updates from the FDA?

As long as your computer is connected to the Internet and your company does not have a firewall that prevents automatic updates of software, the software auto-updates each time it is opened.

Q11. What if my company has a firewall that prevents automatic updates of software?

A solution may be to install the software on a company server that allows for auto-updates. Users can access the application from the server.

Q12. How can I store the eSubmissions for record keeping in my company?

The data (.xml) file and zip file can be named and stored just like any other electronic document.

Q13. Is the FDA eSubmitter software Part 11 Compliant?

Yes, the software has the ability to maintain all the data files that are produced and submitted to the FDA.

Q14. Where can I find more information on the appropriate and efficient use of the FDA eSubmitter software (i.e. User Manual, etc)?

You can download the FDA eSubmitter User Manual.  In addition, FDA eSubmitter has a help feature in the tool bar.

Q15. Is there a technical support number for questions or troubleshooting?

Yes, the Technical Support staff is available every working day to assist with technical issues. 

Q16. Whose name and mailing address appears on the Submittal Letter generated by the FDA eSubmitter?

For the Submittal Letter, the software uses the name of the primary sponsor/applicant in the Contact Identification and the address in the Mailing Location first. If the Mailing Location address is empty, the software then uses the address in the Physical Location.

Q17. How can I include information on the Secondary Contact in the Submittal Letter generated by the FDA eSubmitter?

If the Submittal Letter is generated in Word (not PDF or HTML), any changes can be made to the letter before it is printed out.

Technical

Q18. What are the computer and system requirements to run the FDA eSubmitter?

  • Windows Operating System
     NOTE: If installing on Vista, please see the additional Instructions for Using eSubmitter on Microsoft Vista.
  • Adobe Acrobat Reader v5.0 or greater.
  • 30 MB of disk space
  • Access to a Compact Disk-Recordable drive ( CD-ROM Drive)
  • Software capable of viewing HTML, such as a Web browser, Microsoft Word
  • Adobe Acrobat (full install version, not the Reader)

Q19. What are the known compatibility issues with FDA eSubmitter running on a Windows Vista operating system?

The FDA eSubmitter application has compatibility issues with the Windows Vista Operating System. By default, the FDA eSubmitter application was previously installed in the following directory: C:\Program Files\eSub. The FDA eSubmitter application appears to run as intended until you attempt to generate any of the output files (e.g., view the Missing Data Report or package files for submission).

It appears that Vista does not allow data files to be created under the Program Files directory. Vista restricts this area to be solely for applications and not for file creation or modification by the user. In addition, since the submission files created are XML based, Vista may also view these as potential configuration files and may choose to hide them from the user’s view. Please see the additional Instructions for Using eSubmitter on Microsoft Vista.

Q20. I am planning to install FDA eSubmitter on Windows Vista. How do I proceed?

Ensure that you install version 1.28.01 or later. The compatibility issues have been resolved in FDA eSubmitter v1.28.01. If you have not installed FDA eSubmitter prior to January 8, 2008, you should not encounter any compatibility issues. See the nearby link for Download and Installing the FDA eSubmitter application. The application will install the data and output folders outside of Program Files in the following location: C:\Users\Public\eSub_Home\

NOTE: Do not change your Preferences within FDA eSubmitter to move the location of the data and output folders into the eSub directory under Program Files.

Q21. I installed FDA eSubmitter on an earlier version of Windows and I have since upgraded to Windows Vista. What are my potential issues?

Please see Instructions for Using eSubmitter on Microsoft Vista for detailed instructions on how to change your preferences within FDA eSubmitter to redirect your data and output folders. If you have existing FDA eSubmitter files, you will need to retrieve your existing submission files from Vista’s Virtual Store and restore any backup files that were created in Windows XP or earlier.

Q22. How do I "Bundle" 510(k) submissions using the FDA eSubmitter software?

In section 1.0 of the Admin tab, the software asks you “Is this a bundled submission?” You must answer “Yes” to this question in order to bundle your 510(k) submission. When completing the submission it is important to identify which assay is being referred to when responding to questions, i.e. answer the question for each assay separately but in the same text response box.

Q23. What if a question or section does not apply to my device?

Questions containing business rules were put in place to disable questions that do not apply to certain devices. If a question still does not apply to your device, enter NA with an explanation as to why the question does not apply. As a preventative measure the software then opens a dialog box and reminds you that it is very important to the FDA’s review process that the required questions be answered with an executive summary. If you still believe the question does not apply click “Ignore” and proceed with the rest of the questions.

Q24. How do I attach files?

A file can be attached to a specific question to provide additional information to the Executive Summary. Attaching a file to an FDA eSubmitter question is very similar to attaching a file to an email. Please see section 5.2.1 of the User Manual available through the nearby Download and Installation link.

Q25. What types of files can I attach?

The following file types can be attached to a file attachment question:

  • Adobe Acrobat files (.pdf)
  • SAS System XPORT files (.xpt)
  • Extensible Markup Language (.xml, .dtd)
  • Standard Generalized Markup Language Files (.sgml)
  • MDL Molfiles (.mol)
  • Excel Files (.xls, .csv)

Q26. Can I attach SAS XPORT files as a PDF?

No, our reviewers and statisticians would like to use the SAS files to reanalyze your data if necessary and SAS XPORT files attached as a PDF document are not useable. Please attach SAS files in SAS XPORT format (.xpt).

Q27. Can I cut and paste text into the text boxes in the FDA eSubmitter software?

Yes, but be sure to review the formatting of the pasted text. Pasted text from a Word Document may include unwanted formatting tags. The two ways to prevent unwanted tags are to use Paste Special when pasting text or first copy the text into a Text file and copy and paste the text from the text file into the appropriate FDA eSubmitter question.

Q28. What if I do not find a relevant section or question for the information that I want to include in the eSubmission?

Section 7.0 located at the end of the OIVD Submission template asks for “Other Supportive Information.” This is a good place to include information that did not have a specific question associated with it.

Q29. Can I view an individual submission on multiple computers?

Yes, there are two ways that users can collaborate on one submission:

  1. The FDA eSubmitter application can be installed on a server and accessed by multiple users simultaneously. To do this when downloading the software, change the default location (your local hard drive at C:\Program Files\eSub) to the location of the server you wish to work from. There is a file locking feature so two users do not access the same submission file at the same time and potentially overwrite each other’s work. If you decide to use a server it is important to remember that all files that are attached to the questions in the submission MUST be saved to the server.
  2. The data file can be passed from one user to another. The submission can be accessed by placing the data file in the data folder and opening it from FDA eSubmitter application.

Q30. Can an old eSubmission be reused to generate a new eSubmission by editing it to include the new information for a similar device?

Yes, to do this you will need to open the old eSubmission and do a "File>Save As" to create a new eSubmission. The template will be updated into the latest version. If new questions were added, they will need to be completed. If questions were removed from the template, the data from those questions will be dropped.

Q31. What do I do if I "package" the eSubmission and then decide to make a change?

Open the eSubmission and make the change then simply repackage the eSubmission.

Q32. What if I want to make a change to a file after it has been attached to a question in the eSubmission?

Simply go to the file at its current location, make the change and save it to the same location. The content of an attached file can change as long as the location of the file does not change.

Q33. Should I set security settings or passwords on my PDF files that are attached to the questions in the eSubmission?

No, please do not set any security settings on the attached PDF files. This could cause issues when the Reviewers access the file.

Q34. Which PDF versions are supported by the FDA eSubmitter software?

Adobe v5.0 or greater

Q35. Can I attach pictures or plug-ins to the questions in the eSubmission?

No, only the following file types can be attached to a question in the eSubmission:

  • Adobe Acrobat files (.pdf)
  • SAS System XPORT files (.xpt)
  • Extensible Markup Language (.xml, .dtd)
  • Standard Generalized Markup Language Files (.sgml)
  • MDL Molfiles (.mol)
  • Excel Files (.xls, .csv)

Q36. Can I use bookmarks in my PDF attachments?

Yes, the PDF files that contain bookmarks are very useful to the FDA Reviewers. It facilitates a faster review time, especially when the attached files are large.

Q37. Can I scan documents and include them as attachments?

Yes, but please run Optical Character Recognition (OCR) to make the PDFs searchable and allow for copying and pasting of the text.

Q38. How should I name the attached PDF files?

Use a descriptive name so the reviewer can easily identify the content of the file, for example: Linearity Study, Product Labeling, etc.

Q39. What is the recommended font for the PDF attachments?

Please use a font that is easy to read on a computer screen, for example: Arial or Times New Roman at 12pt.

Q40. What if the standard I want to reference in the eSubmission (section 7.0 of the Admin tab) is not listed in the FDA eSubmitter software database?

In this section there is a question that asks you “Did you reference any other standards?” if yes is selected from the drop down list, then question “7.1 Other Standards” becomes activated and you are then able to reference the standard. You can attach a copy if there are no copyright restrictions.

Q41. What if I get a message that says my file cannot be viewed because it cannot be located?

This message may indicate that the file is not in the same location as it was when it was first attached. There are two ways to fix this error:

  1. Move the file back into the first location
  2. Remove the file from the file attachment list and reattach the file from its current location.

Q42. What does it mean when I get a message indicating that the FDA eSubmitter template will become “inactive?”

Updates occur to the templates each month. Questions are removed or added, new business rules are implemented, new templates are developed, and standards, guidance, and product codes are updated. In order for the FDA to ensure that users are using the most updated templates, the templates are set to expire one year after a new version is released. If you have been working on an eSubmission using the old template you must submit the eSubmission within one year of the last update for the FDA to be able to load and review your eSubmission. Otherwise you can do a File>Save As to the update to the latest version of the template.

Q43. What happens if I change the location of the project files after the CD was burned (if I try to open the FDA eSubmitter application for the specific project)?

If the files are not in the original location, the software will not be able to open the files. You can reference the submission from the location where the packaged zip file is stored.

Q44. Does FDA eSubmitter perform an "autosave?"  If it does, can it be turned off?

Yes, the FDA eSubmitter application has the ability to set an auto-save feature. This feature can be customized by going to File>Preferences. When this option is enabled, FDA eSubmitter automatically saves your submission while you work. You can also set the interval for how often you want to save. At default, auto-save is automatically turned on, and set to save files at 10 minute intervals. It is also possible to turn off the auto save feature from within the Preferences.

Q45.Once I package the completed submission, what do I burn to the CD?

ONLY BURN THE ZIP FILE located in the Output folder to the CD. Do not add any other folders or save any other files to the CD. This is very important because if you add any folders or files other than the zip file to the CD, the loading application will not be able to load your eSubmission to the online Reviewing system. The review could be delayed until the IT staff manually identifies the zip file on the CD and loads it for review.