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Today, the U.S. Food and Drug Administration (FDA) issued an updated draft guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
The Medical Device User Fee Amendments of 2022 (MDUFA V) includes refined performance goals related to FDA feedback for Pre-Submissions or “Pre-Subs,” which are part of the Q-Submission Program. Additionally, as part of MDUFA V, the FDA committed to issuing a revised draft guidance by March 31, 2024, including information on when informal communication is appropriate instead of a Pre-Sub. This updated draft guidance meets this commitment.
This updated draft guidance provides:
- Information to assist applicants and FDA staff in identifying when an informal communication would generally be appropriate instead of a Pre-Submission or other Q-Submission type,
- Additional information on the scope of Q-Submission types, as well as clarifications to existing policies and procedures,
- Content from “Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry,” with no changes to existing policies and procedures for PMA Day-100 Meetings, and
- Revised examples of common review topics and questions.
Note: This draft guidance is not for implementation.
Submit comments on this draft guidance:
Submit comments under docket number FDA-2018-D-1774 at www.regulations.gov by May 14, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the Division of Industry and Consumer Education.
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