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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%

Expanded Access requests outside of an IDE are limited to single patient compassionate use requests.
Evaluable requests are those sufficiently complete for FDA’s review and resulted in a decision to approve or deny.
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

CDRH Expanded Access Requests Fiscal Year (FY) 2014 - 2017

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
 
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