Earlier this week, the Food and Drug Administration (FDA) issued
a proposed rule amending its regulations on the acceptance of data
from clinical studies on medical devices. The proposed rule
requires that clinical studies outside the United States as support
for any device-related application or submission –
investigational device exemption (IDE), premarket notification
(510(k)), premarket approval (PMA), product development protocol
(PDP), or humanitarian device exemption (HDE) – have been
conducted in accordance with good clinical practices (GCP).
The proposed rule also requires GCPs to have been followed in
clinical studies conducted inside the US for FDA to accept the data
in support of an IDE or 510(k). For purposes of the proposed rule,
GCPs include "a standard for the design, conduct, performance,
monitoring, auditing, recording, analysis, and reporting of
clinical trials in a way that provides assurance that the data and
reported results are credible and accurate and that the rights,
safety, and well-being of trial subjects are protected." GCPs
further include "review and approval (or provision of a
favorable opinion) by an independent ethics committee (IEC) before
initiating a study, continuing review of an ongoing study by an
IEC, and obtaining and documenting the freely given informed
consent of the subject ... before initiating a study." An
institutional review board (IRB) qualifies as an IEC.
FDA offered four general reasons in support of the proposed
rule: (1) to update its standards for accepting data from clinical
studies on medical devices conducted outside the US; (2) to ensure
the quality and integrity of data; (3) to standardize protections
for human subjects; and, (4) to clarify the requirements for FDA
acceptance of data from clinical studies in support of IDEs and
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