Cardiology

FDA has approved draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices, according to a press release.

“Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval,” FDA Center for Devices and Radiological Health director Jeffrey Shuren, MD, stated in the news release. “As medical devices grow increasingly complex, many factors impact our benefit-risk determinations, especially for PMA devices. This guidance aims to provide more clarity to manufacturers about what factors we consider when making an approval decision.”

The guidance focuses on the regulatory pathway for high-risk medical devices: premarket approval applications (PMAs). Recommendations within the guidance are intended to improve predictability, consistency and transparency of the premarket review process for applicable devices, and could help manufacturers navigate the approval process more easily, the release noted.

Safety and effectiveness data make up the FDA’s review of PMAs, with safety data addressing risk and the device manufacturer’s ability to mitigate such risk. Effectiveness data considers benefits and other information in determining whether the benefits of using the device outweigh the risks.

According to the release, however, safety and effectiveness data alone may not provide a complete picture of the benefits and risks involved. For this reason, FDA medical device reviewers examine factors like the severity of the disease the product diagnoses or treats — as well as whether or not alternative tests or treatments may be available. Reviewers also might take into account whether a device should be considered new or first-of-its-kind, especially if it treats a disease with no other treatment.

The guidance also proposes medical device reviewers use a worksheet to document how they make benefit-risk determinations, the release noted, adding that in certain cases such a document could be made public post-approval — enhancing the transparency of the FDA’s decision-making process.