The following is the summary of medical device technical review in January 2024:
Submissions Overview | In Process of Technical Review:1311 |
Technical Review Completed:1331 | |
Submissions Accepted | Document Review:1576 |
Submissions Accepted:2113 | |
Filing Modification :933 | |
Import Class I Device Filing:187 | |
RFEs and Responses to RFEs | RFE released: 643 |
RFE Response Accepted: 540 | |
Advisory Meetings | Meeting initiated: 5 |
Meeting conducted: 13 | |
PAI (Preapproval QMS Inspection) | PAI Initiated: 3,439 |
PAI Completed: 3,170 | |
Special review of innovative medical devices | Submission: 58 |
Organize expert review meetings: 35 | |
Complete review: 37 | |
Priority approval of medical device review | Submission:7 |
Review Completes: 6 |