FDA proposes guidelines for benefit-risk determinations of medical devices

For Immediate Release: The U.S. Food and Drug Administration has, for the very first time, provided a draft set of guidelines to elucidate benefit-risk determinations for pre-market review of some medical devices.

The guidelines released on Aug 15, 2011, emphasize on the regulatory conduct for high-risk medical devices, which is covered by the pre-market approval applications (PMAs). As per the recommendations in the guidelines, the pre-market review process for applicable devices will undergo an improvement in the consistency, predictability, and transparency, which will facilitate easily navigation of the approval process for manufacturers.

The agency employed efficacy and safety data for PMA reviews in order to understand the benefits and risks associated with the use of the device. While the efficacy data addresses the benefits to assess whether they prevail over the possible risks, the safety data considers the risk, and the manufacturer’s capability to alleviate it.

Benefits and risks associated with device use may not be entirely assessed by reviewing safety and efficacy data alone. Other aspects including severity of the disease, the product diagnoses, or treats, and the availability or non-availability of alternative tests or treatments are also objectively assessed by the FDA medical device reviewers.
As a part of the benefit-risk determination, device reviewers also may ponder over whether the device is new or a first-of-a-kind technology, especially to treat a disease that has no other treatment.

Director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, M.D, said: “Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval. 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.”

According to the recommendations of the guidance, medical device reviewers are expected to document the process of benefit-risk determinations in a spreadsheet so that this document could be publicized, in certain cases, post approval thus rendering more transparency to the FDA’s decision making process.

For more information: Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review