FDA Publishes Guidance on PMA Device Review Process

April 20, 2012—The US Food and Drug Administration (FDA) has published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during review of premarket approval applications.

The document, "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classification," was published on March 27 and is available for download on the FDA's Web site. The FDA issued a draft of the document for public review and comment in August 2011, as reported in Endovascular Today.

Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health (CDRH), commented, “This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency, and transparency in FDA decision making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations. In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks.”

CDRH reviewers will begin applying the guidance to incoming PMA and de novo submissions, and to those already under review, with decisions beginning on May 1, 2012. CDRH will train medical officers, review staff managers, and device reviewers to ensure that the guidance is applied consistently to submissions and petitions. The FDA is also developing external training modules to help industry and device sponsors understand how CDRH will apply the guidance.

According to the FDA, the guidance outlines the systematic approach that the FDA device reviewers take when making benefit-risk determinations during the premarket review process. It also provides manufacturers with a helpful tool that explains (1) the various principal factors considered by the agency during the review of PMA applications, (2) the regulatory pathway for high-risk medical devices, and (3) de novo petitions—a regulatory pathway available for novel, low-to-moderate–risk devices. Furthermore, the guidance takes into account patients' tolerance for risks and perspective benefits, as well as the novelty of the device, the agency stated.