Summary of medical device technical review in January 2024

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

Submissions OverviewIn Process of Technical Review:1311
Technical Review Completed:1331
Submissions AcceptedDocument Review:1576
Submissions Accepted:2113
Filing Modification :933
Import Class I Device Filing:187
RFEs and Responses to RFEsRFE released:  643
RFE Response Accepted: 540
Advisory MeetingsMeeting initiated:  5
Meeting conducted: 13
PAI (Preapproval QMS Inspection)PAI Initiated: 3,439
PAI Completed: 3,170
Special review of innovative medical devicesSubmission: 58
Organize expert review meetings: 35
Complete review: 37
Priority approval of medical device reviewSubmission:7
Review Completes: 6