GUIDANCE DOCUMENT
Electronic Submission Template for Medical Device De Novo Requests Draft Guidance for Industry and Food and Drug Administration Staff September 2023
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
Submit Comments by
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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
- Docket Number:
- FDA-2023-D-3788
- Issued by:
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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological Health
FDA is issuing this draft guidance document to introduces submitters of De Novo requests to the Center for Devices and Radiological Health and Center for Biologics Evaluation and Research to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission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. When finalized, this guidance will provide further standards for the submission by electronic format, a timetable for establishment of these further standards, and criteria for waivers of and exemptions from the requirements.