Today the FDA issued both the final rule on “Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” and the guidance document “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions.”  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 guidance document “FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions ” 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.