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GUIDANCE DOCUMENT

Electronic Submission Template for Medical Device De Novo Requests Guidance for Industry and Food and Drug Administration Staff August 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2023-D-3788
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

This guidance provides the standards for the submission of De Novo Requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also 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. As of October 1, 2025, FDA will require that De Novo Request electronic submissions be provided as described in this guidance.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-3788.

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