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# De Novo e-Submission Template Guidance
- URL: https://www.fdaweb.com/de-novo-e-submission-template-guidance/
- Published: 2023-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:59:12.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155435

FDA has published a draft guidance, *Electronic Submission Template for Medical Device De Novo Requests*, to introduce *de novo* request submitters to the current resources and associated content developed and made publicly available to support *de novo* electronic submissions to the agency. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-submission-template-medical-device-de-novo-requests?utm%5Fmedium=email&utm%5Fsource=govdelivery) says it “is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.”

A media [release](https://content.govdelivery.com/accounts/USFDA/bulletins/3729754?ref=fdaweb.com) on the guidance says the draft:

- introduces the current electronic tool and requested submission content, specifically the eSTAR (Electronic Submission Template And Resource) for preparing *de novo* requests;
- describes significant terminology associated with electronic submissions;
- explains the current electronic submission template structure, format, and use; and
- explains electronic submission template waivers, exemptions, and timing.