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 |