FDA releases final rule on Acceptance of Data from Clinical Investigations for Medical Devices

FDA releases final rule on Acceptance of Data from Clinical Investigations for Medical Devices

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

investigations.

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

Medical Device Applications and Submissions Frequently Asked Questions ” on the same

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 dice@fda.hhs.gov.