On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted outside of the United States (“OUS”). The guidance arises from the 2012 Food and Drug Administration Safety and Innovation Act § 1123, amending Food, Drug & Cosmetic Act § 569B, which codified FDA’s longstanding practice of accepting scientifically-valid clinical data obtained from foreign clinical studies in support of premarket submissions for devices. Thus, the guidance is not intended as a new policy announcement, but rather as a description of FDA’s existing approach to this topic.
The draft guidance highlights special considerations that apply when using foreign clinical data, including applicability to populations within the US, and provides recommendations to assist sponsors in ensuring their data are adequate under applicable FDA standards. Specifically, FDA focuses on considerations sponsors of device submissions should take into account when initiating, or relying on previously collected data from a foreign clinical study to support an Investigation Device Exemption (IDE), Premarket Notification (510k), De Novo Petition, Humanitarian Device Exemption (HDE), or Premarket Approval Application (PMA). To illustrate these considerations, FDA includes in the draft guidance several hypothetical examples depicting when data will be acceptable.
As noted in the draft guidance, the number of IDE applications and submissions for marketing authorization supported by OUS clinical trials has increased in recent years and will likely continue to increase in the future. This increasing globalization of clinical trials presents challenges to both US and foreign regulators. Among the challenges are resource constraints that impact the number of foreign clinical site inspections and unnecessary duplication of clinical studies and administrative burdens. As such, in publishing the draft guidance, FDA believes that promoting greater clarity concerning the Agency’s use of foreign study data will minimize the possibility for additional or duplicative U.S. studies, further efforts to harmonize global clinical trial standards, and promote public health and innovation.
Comments on the draft guidance are due to FDA by July 20, 2015 and can be submitted here.