FDA published a revised Final Guidance on “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program” on June 2, 2023. The revised guidance includes requirements for how FDA provides feedback through the Q-Sub process in line with goals outlined in MDUFA V.
Minor Updates
- Clarification of the use of the Q-Sub process for accessory classification requests
- Meeting minutes should summarize the Q-Sub discussion rather than read like a transcript
- Additional language that states that sponsors should not expect FDA to provide feedback on information that is introduced after submitting the pre-submission package.
- Any eCopy submission packages should be submitted via the CDRH Customer collaboration portal
- Pre-sub meeting should be held on days 70-75
- Keep the length of the meeting to 1 hour; needing more time than that might indicate that the Q-Sub should be more limited in scope
Major Updates
- Direction to get feedback on AI/ML Predetermined Change Control Plans (PCCPs) before including in a premarket submission.
- Safer Technologies Program (STeP) as a type of submission in the Q-Submission program.