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Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff March 2024

Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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.

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The purpose of this draft guidance document is to provide an overview of the mechanisms available to submitters through which they can request interactions with the Food and Drug Administration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 This draft guidance revises the 2023 guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The 2023 final guidance remains for implementation until this draft guidance is finalized.

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-2018-D-1774.

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