FDA looks to clarify benefit-risk determinations for medical devices

The FDA today has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The guidance, which focuses on PMAs, is intended to help those involved in designing clinical studies in support of premarket submissions.

In its review of PMAs, the FDA uses safety and effectiveness data. But these data alone may not provide a complete picture of the benefits and risks of a device. Agency reviewers study other factors, including the severity of the disease the product diagnoses or treats and whether alternatives are available. They also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination.

In addition, the guidance proposes that medical device reviewers use a worksheet to document how they make benefit-risk determinations. In certain cases, this document could be made public post-approval, making the FDA's decision-making process more transparent.

"Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval," said CDRH head Jeffrey Shuren in a statement. "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."

Comments are due Nov. 14. The draft can be accessed at the regulations.gov website.

- see the FDA statement