The US Food and Drug Administration (FDA) has published the final version of its guidance document titled ‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’, superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of interaction with the Agency:
A. Pre-Submissions (Pre-Subs)
B. Submission Issue Requests (SIRs)
C. Study Risk Determinations
D. Informational Meetings
E. Other Q-Submission Types
The guidance also explains which interactions are not within the Q-Submission Program, and provides information on the Q-Sub process and the recommended content of Q-Sub submissions, dependant on the type of Q-Sub..