Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This draft guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This draft guidance, when finalized, is intended to supersede the document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" issued on June 2, 2023, and provides clarification and additional information on the scope of Q- Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre- Submission or other Q-Submission types), and improved examples. This draft guidance is not final nor is it for implementation at this time.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.