FDA provides clarification on benefit-risk determinations for medical devices guidelines

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The US Food and Drug Administration (FDA) has provided draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices.

The guidance focuses on premarket approval applications (PMAs), the regulatory pathway for high-risk medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily.


In its review of PMAs, the FDA uses safety data and effectiveness data. The safety data addresses risk, and the manufacturer’s ability to mitigate that risk. The effectiveness data considers benefits, as well as other information, to determine whether the probable benefits outweigh the probable risks associated with use of the device.


Safety and effectiveness data alone may not provide a complete picture of the benefits and risks. FDA medical device reviewers objectively look at other factors such as the severity of the disease the product diagnoses or treats and whether or not alternative tests or treatments are available.


Device reviewers also may consider whether the device is new or a first-of-a-kind technology as part of the benefit-risk determination, particularly if the device treats a disease that has no other treatment.


“Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “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 also 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 even more transparent.


Extended guidance information can be found on https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo…

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