FDA Updates Q-Submission Program for Better Device Meetings
Published Date: 5/29/2025
Notice
Summary
The FDA just updated its guide on how medical device makers can ask for feedback and meetings through the Q-Submission Program. This helps companies get clearer, faster answers when submitting new devices, saving time and avoiding confusion. If you’re in the medical device world, this means smoother communication with the FDA starting now—no extra costs, just better clarity!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Final Q-Submission Guidance Released
The FDA announced the availability of a final guidance titled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This final guidance supersedes the prior Q-Sub guidance issued on June 2, 2023 and is now the current FDA guidance for submitters.
Scope of Q-Sub Types Clarified
The guidance provides clarification and additional information on the scope of Q-Submission (Q-Sub) types. It also better delineates how to obtain feedback for different types of questions, such as informal communication versus Pre-Submission or other Q-Sub types.
Improved Examples for Submitters
The final guidance includes improved examples illustrating how to request interactions with FDA for medical device submissions. These examples are intended to help submitters understand which Q-Sub type to use and how to frame questions to FDA staff.
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