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 |