Electronic Submission Template for Medical Device Q-Subs Guidance

Submit Comments by 07/28/2025

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2025-D-1082

Docket Number: FDA-2025-D-1082 Issued by:

Guidance Issuing Office

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

FDA is issuing this draft guidance document to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-Subs), to the Center for Devices and Radiological Health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 Pre-Sub 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 This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission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 standards for the submission by electronic format, a timetable for when the FDA intends to require Pre-Subs to be provided in electronic format, and criteria for waivers of and exemptions from the requirements.

• Content current as of:

  05/28/2025

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