PMA Day 100 meeting

The meeting gives the applicant early feedback on the review status and on any major deficiencies. Asking for it is the applicant's choice, and it can save a review cycle.

A PMA Day 100 Meeting is a meeting with the FDA that fulfills FDA’s obligation, upon written request from the applicant, to meet with the applicant no later than 100 days after the receipt of an original PMA application that has been filed.

FDA guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (May 2025), Section II.E, PMA Day 100 Meetings