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# AdvaMed Comments on Electronic Submission Guide
- URL: https://www.fdaweb.com/advamed-comments-on-electronic-submission-guide/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155881

AdvaMed says it appreciates FDA efforts to develop a draft guidance to help support a process for electronic submissions with a De Novo electronic template. The association’s comment [letter](https://downloads.regulations.gov/FDA-2023-D-3788-0003/attachment%5F1.pdf?ref=fdaweb.com) raises these concerns for the agency to consider as it develops a final guidance:

- ensure the De Novo eSTAR guidance includes sufficient information to understand the technical standards of the electronic submission template;
- provide flexibility in the De Novo eSTAR template to accommodate large files and diverse content;
- provide a mechanism for feedback on changes to the eSTAR template; and
- allow waivers and exemptions under appropriate circumstances.