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GUIDANCE DOCUMENT

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Submit Comments Online

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2018-D-1774

Docket Number:
FDA-2018-D-1774
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

The purpose of this draft guidance document is to provide an overview of the mechanisms available to submitters through which they can request interactions with the Food and Drug Administration (FDA) related to medical device submissions. This draft guidance revises the 2023 guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The 2023 final guidance remains for implementation until this draft guidance is finalized.

 
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