Understanding the Q-Submission Guidance Change


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.

Back to Blog