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.

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CDRH Expanded Access Requests (2014-2018)

FY 2014-2018 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
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