FDA considers patient preference on benefit-risk trade-offs in medical devices
The FDA is prepared to take patient preference into consideration when determining what level of risk is appropriate for the potential risks associated with medical devices.
The FDA is looking to make some updates to its medical device benefit-risk calculations, taking into greater consideration the preferences of patients, caregivers and healthcare workers.
The federal watchdog agency is holding a public workshop to solicit suggestions on how its medical device review arm might better assess and incorporate patient perspectives on "meaningful benefits" and "appropriate risks" of new medical devices. The agency has in the past considered patient preference an important part of the review process, but lacks systematic tools to gather, assess and utilize relevant data.