Summary of medical device technical review in March 2024

The following is the summary of medical device technical review in March 2024:

Submissions OverviewIn Process of Technical Review:1371
Technical Review Completed:1254
Submissions AcceptedDocument Review:1423
Submissions Accepted:2140
Filing Modification :801
Import Class I Device Filing:242
RFEs and Responses to RFEsRFE released:  607
RFE Response Accepted: 639
Advisory MeetingsMeeting initiated:  12
Meeting conducted: 16
PAI (Preapproval QMS Inspection)PAI Initiated: 319
PAI Completed: 205
Special review of innovative medical devicesSubmission: 26
Organize expert review meetings: 44
Complete review: 48
Priority approval of medical device reviewSubmission:7
Review Completes: 5