Expanded Access (Compassionate Use) Submission Data Archive: CDRH
CDRH IDE Expanded Access Requests (2014-2017)1
Expanded Access Totals | FY 2014 | FY 2015 | FY 2016 | FY 2017 |
Requested Received |
218 |
222 |
136 | 100 |
Evaluable Requests2 |
212 |
211 |
124 | 96 |
Approved |
211 |
210 |
123 | 96 |
Percentage Approved3 |
99.5% |
99.5% |
99.2% | 100.0% |
CDRH Non-IDE Expanded Access Requests (2014-2017)1
Expanded Access Totals | FY 2014 | FY 2015 | FY 2016 | FY 2017 |
Requested Received |
179 |
167 |
198 | 230 |
Evaluable Requests2 |
167 |
155 |
196 | 220 |
Approved |
165 |
154 |
196 | 220 |
Percentage Approved3 |
98.8% |
99.4% |
100.0% | 100.0% |
1 Expanded Access requests outside of an IDE are limited to single patient compassionate use requests.
2 Evaluable requests are those sufficiently complete for FDA’s review and resulted in a decision to approve or deny.
3 Based on approved requests to total number of evaluable requests.
CDRH Expanded Access Requests (2014-2017)
FY 2014-2017 Graph of CDRH Expanded Access Requests
IDE Expanded Access Requests
Year | Approved | Disapproved |
---|---|---|
FY 14 | 211 | 1 |
FY15 | 210 | 1 |
FY 16 | 123 | 1 |
FY 17 | 96 | 0 |
Non-IDE Expanded Access Requests
Year | Approved | Disapproved |
---|---|---|
FY 14 | 165 | 2 |
FY15 | 154 | 1 |
FY 16 | 196 | 0 |
FY 17 | 220 | 0 |