The following is the summary of medical device technical review in April 2024:
Submissions Overview | In Process of Technical Review:1500 |
Technical Review Completed:1439 | |
Submissions Accepted | Document Review:1629 |
Submissions Accepted:2401 | |
Filing Modification :939 | |
Import Class I Device Filing:262 | |
RFEs and Responses to RFEs | RFE released: 659 |
RFE Response Accepted: 561 | |
Advisory Meetings | Meeting initiated: 14 |
Meeting conducted: 10 | |
PAI (Preapproval QMS Inspection) | PAI Initiated: 324 |
PAI Completed: 389 | |
Special review of innovative medical devices | Submission: 42 |
Organize expert review meetings: 23 | |
Complete review: 53 | |
Priority approval of medical device review | Submission:4 |
Review Completes: 7 |