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VA Technical Reference Model v 25.5

FDA eSubmitter
FDA eSubmitter Technology

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website: Go to site
Description: The Food and Drug Administration (FDA) eSubmitter software allows participants to electronically complete and submit information for various products to participating centers within the FDA. This technology is intended to automate the current paper submission process, allowing for quicker completion, as well as speed up the filing process with FDA. The FDA eSubmitter software requires completing a series of questions in electronic forms and allows attaching documents, images, and media files when additional information is needed. FDA eSubmitter is part of an electronic submissions program that is available for voluntary use by sponsors, manufacturers, and importers to create a variety of submission types within the drug, blood, device, radiological health, tobacco, and animal drug regulated industries.

The software and any output files reside locally on a user`s computer, allowing a user to work on a submission offline, save, and continue later. The FDA does not have the ability to access, review, or supplement the information on a user`s computer through this application.
Technology/Standard Usage Requirements: Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information System Security Officer (ISSO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information: This technology has not been assessed by the Section 508 Office. The Implementer of this technology has the responsibility to ensure the version deployed is 508-compliant. Section 508 compliance may be reviewed by the Section 508 Office and appropriate remedial action required if necessary. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov.
Decision: View Decisions
Decision Source: TRM Mgmt Group
Decision Process: One-VA TRM v24.7
Decision Date: 07/15/2024 at 19:06:11 UTC
Aliases: FDA Submission Software
Introduced By: TRM Request
Vendor Name: FDA
- The information contained on this page is accurate as of the Decision Date (07/15/2024 at 19:06:11 UTC).