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# De Novo Electronic Submission Template
- URL: https://www.fdaweb.com/de-novo-electronic-submission-template/
- Published: 2024-08-22T12:00:00.000Z
- Updated: 2026-09-14T14:39:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157630

FDA has published a 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 FDA. 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), FDA says, 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.”

The guidance has an Introduction; Background; Scope; Significant Terminology; and Electronic Submission Template, Waivers, Exemptions, and Timing.