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Expanded Access (Compassionate Use) Submission Data Archive: CDRH

CDRH IDE Expanded Access Requests (2014-2015)1

 

FY 2014

FY 2015

Requested Received

218

222

Evaluable Requests2

212

211

Approved

211

210

Percentage Approved3

99.5%

99.5%

 

CDRH Non-IDE Expanded Access Requests (2014-2015)1

Expanded Access Totals

 

FY 2014

FY 2015

Requested Received

179

167

Evaluable Requests2

167

155

Approved

165

154

Percentage Approved3

98.8%

99.4%

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 (2014-2015)

FY 2014-2015 Graph of CDRH Expanded Access Requests

FY 2014-2015 Graph of CDRH Expanded Access Requests Bar Graph
    Approved Disapproved
IDE Expanded Access Requests FY 14 211 1
  FY 15 210 1
Non-IDE Expanded Access Requests FY 14 165 2
  FY 15 154 1
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