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GUIDANCE DOCUMENT

Electronic Submission Template for Medical Device Q-Submissions Draft Guidance for Industry and Food and Drug Administration Staff May 2025

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

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FDA is issuing this draft guidance document to introduce submitters of certain Q-Submissions (Q-Subs), specifically Pre-Submissions (Pre-Subs), to the Center for Devices and Radiological Health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 This draft guidance is intended to represent one of several steps in meeting FDA’s commitment to the development of electronic submission templates to serve as guided submission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.

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-2025-D-1082.

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