The FDA is proposing to amend its regulations on acceptance of data from clinical studies for medical devices | Regulatory Doctor

[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)] | Regulatory Doctor 
[Proposed Rules]
[Pages 12664-12675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04201]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 807, 812, and 814

[Docket No. FDA-2013-N-0080]
RIN 0910-AG48

Human Subject Protection; Acceptance of Data From Clinical 
Studies for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations on acceptance of data from clinical studies for medical 
devices. We are proposing to require that clinical studies conducted 
outside the United States as support for an investigational device 
exemption (IDE) application, a premarket notification (510(k)) 
submission, a premarket approval (PMA) application, a product 
development protocol (PDP) application, or a humanitarian device 
exemption (HDE) application be conducted in accordance with good 
clinical practice (GCP), which includes obtaining and documenting the 
review and approval of the study by an independent ethics committee 
(IEC) and obtaining and documenting freely given informed consent of 
study subjects. The proposed rule is intended to update the standards 
for FDA acceptance of data from clinical studies conducted outside the 
United States and to help ensure the protection of human subjects and 
the quality and integrity of data obtained from these studies. As part 
of this proposed rule, we are also proposing to amend the IDE and 
510(k) regulations to address the requirements for FDA acceptance of 
data from clinical studies conducted inside the United States. The 
proposed amendments are intended to provide consistency in FDA 
requirements for acceptance of clinical data, whatever the application 
or submission type.

via Federal Register, Volume 78 Issue 37 (Monday, February 25, 2013).

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