Expanded Access (Compassionate Use) Submission Data Archive: CDRH
CDRH IDE Expanded Access Requests (2014-2016)1
| Expanded Access Totals | FY 2014 | FY 2015 | FY 2016 |
|
Requested Received |
218 |
222 |
136 |
|
Evaluable Requests2 |
212 |
211 |
124 |
|
Approved |
211 |
210 |
123 |
|
Percentage Approved3 |
99.5% |
99.5% |
99.2% |
CDRH Non-IDE Expanded Access Requests (2014-2016)1
| Expanded Access Totals | FY 2014 | FY 2015 | FY 2016 |
|
Requested Received |
179 |
167 |
198 |
|
Evaluable Requests2 |
167 |
155 |
196 |
|
Approved |
165 |
154 |
196 |
|
Percentage Approved3 |
98.8% |
99.4% |
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 (2014-2016)
FY 2014-2016 Graph of CDRH Expanded Access Requests
IDE Expanded Access Requests
| Year | Approved | Disapproved |
|---|---|---|
| FY 14 | 211 | 1 |
| FY15 | 210 | 1 |
| FY 16 | 123 | 1 |
Non-IDE Expanded Access Requests
| Year | Approved | Disapproved |
|---|---|---|
| FY 14 | 165 | 2 |
| FY15 | 154 | 1 |
| FY 16 | 196 | 0 |