On February 20, the FDA issued the final rule on “Human Subject Protection; Acceptance of
Data from Clinical Investigations for Medical Devices .” The rule updates the FDA’s
standards for accepting clinical data from clinical investigations conducted both inside
and outside the United States to help ensure the protection of human participants, and to
help ensure the quality and integrity of data obtained from these clinical
The final rule amends FDA regulations on acceptance of data from clinical investigations
conducted outside the United States to reflect the increasing globalization of clinical
trials and the evolution of clinical trial standards for protecting human subjects. The
new rule requires that sponsors and applicants provide statements and information about
how the investigations conform with good clinical practices (GCP). This applies to
clinical data submitted to support investigational device exemptions (IDE), premarket
notifications (510(k)), requests for De Novo classification, premarket approvals (PMA),
product development protocols (PDP), and humanitarian device exemptions (HDE). The FDA
believes that the requirements set out in the final rule provide flexibility for medical
device sponsors conducting multinational clinical trials by allowing them to describe the
standard for good clinical practice they followed.
The final rule also amends the IDE, 510(k) and HDE regulations for FDA acceptance of data
from clinical investigations conducted within the United States to require a statement
regarding compliance with FDA regulations for human subject protection, institutional
review boards, and IDEs. This change is intended to provide consistency across different
submission or application types.
The FDA also published the guidance document “FDA Acceptance of Clinical Data to Support
date. The guidance document is in question and answer format, and provides clarifications
and recommendations to help stakeholders ensure that studies conducted in the U.S. or
foreign countries comply with the new rule and revised regulations.
If you have any questions about the final rule, please contact the Division of Industry
and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at
1-800-638-2014, 301-796-7100 or firstname.lastname@example.org.