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Expanded Access (Compassionate Use) Submission Data Archive: CDRH

Expanded Access (Compassionate Use) Submission Data Archive: CDER and CBER

CDRH Archived Data (2014-2018)

CDRH IDE Expanded Access Requests (2014-2018)1

Expanded Access Totals FY 2014 FY 2015 FY 2016 FY 2017 FY 2018

Requests Received

218

222

136 100 79

Evaluable Requests2

212

211

124 96 69

Approved

211

210

123 96 69

Percent Approved3

99.5%

99.5%

99.2% 100.0% 100.0%

1Expanded Access IDE requests in CDRH reflect compassionate use (single patient or small population) requests.
2Evaluable requests are decisions in which a substantive review was performed on an expanded access request (individual patient or small group access) resulting in an approval, approval with conditions, or disapproval decision.
3Based on approved requests to total number of evaluable requests.

CDRH Non-IDE Expanded Access Requests (2014-2018)1

Expanded Access Totals FY 2014 FY 2015 FY 2016 FY 2017 FY 2018

Requests Received

179

167

198 230 257

Evaluable Requests2

167

155

196 220 233

Approved

165

154

196 220 232

Percent Approved3

98.8%

99.4%

100.0% 100.0% 99.6%

1Expanded Access requests outside of an IDE are limited to single patient compassionate use requests.
2Evaluable requests are requests in which a substantive review was performed on an original, non-IDE compassionate use request resulting in an approval/grant or disapproval/denial decision.
3Based on approved/granted requests to total number of evaluable requests.


CDRH Expanded Access Requests (2014-2018)

FY 2014-2018 Graph of CDRH Expanded Access Requests

CDRH Expanded Access Requests Fiscal Year 2014 - 2018

 

IDE Expanded Access Requests

Year Approved Disapproved
FY 14 211 1
FY15 210 1
FY 16 123 1
FY 17 96 0
FY 18 69 0

 

Non-IDE Expanded Access Requests

Year Approved Disapproved
FY 14 165 2
FY15 154 1
FY 16 196 0
FY 17 220 0
FY 18 232 1
 
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