The FDA released a new guidance yesterday detailing the agency’s process of making benefit-risk determinations when assessing premarket applications for medical devices for “reasonable assurance of safety and effectiveness.”
The agency hopes to provide clarity for both industry and its reviewers by outlining what sorts of factors are taken into consideration when considering PMAs, the most stringent of the medical device review processes.
The agency emphasized the need to address a device’s risks, the manufacturer’s ability to mitigate that risk, the benefits of the device, the severity of the disease the device treats or diagnoses and the availability of alternatives, among other things.
This is the second guidance on PMAs the FDA released yesterday, the first providing a detailed outline of the basic structure of a proper clinical trial in support of a PMA submission.
“Clinical data is the foundation for determining the safety and effectiveness of medical devices requiring FDA premarket approval,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “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.”
Also included for public comment was a proposed draft of a worksheet that reviewers may use to make the benefit-risk analysis, which lists a series of factors to review and questions to consider, such as levels of uncertainty in the probability of a harmful event and patient tolerance for risks in light of the condition they suffer from.
The guidance comes complete with examples of devices to review to demonstrate how different factors are considered together when making a final assessment.
The benefit-risk guidance is open for public comment for the next 90 days.