FDA publishes draft guidance on foreign clinical data for medical devices in support of 510(k) premarket submissions

Today the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on:

• FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices
• The special considerations that apply when using OUS data
• Recommendations to assist sponsors in developing data that meet FDA standards to support approval of clearance of the device in the U.S.

This draft guidance focuses on FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States. This guidance is not intended to announce new policy, but to describe FDA’s existing approach to this topic.

Valid scientific evidence, as described under 21 CFR 860.7, is only one factor in determining whether the FDA can use OUS data to support a decision on premarket submission. However, it does not generally address ethical considerations. On February 25, 2013 FDA proposed a rule to address these and other consideration related to good clinical practice for clinical trials. The proposed rule, “Human Subject Protection: Acceptance of Data from Clinical Studies for Medical Devices,” requires that clinical studies conducted outside the United States as support for a premarket submissions be conducted in accordance with good clinical practice (GCP). This 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. In contrast, this guidance is not intended to announce new policy, but to describe FDA’s existing approach to accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices.

If you are looking to market a new medical device and need to speak to an attorney about the FDA process and the regulatory routes to market, please contact Ann Marie Gaitan, Esq. at 305.443.8900 or via e-mail at [email protected].