FDA considers patient preference on benefit-risk trade-offs in medical devices

July 30, 2013 by Arezu Sarvestani

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.

FDA prepared to hear more patient preference on benefit-risk tradeoffs in 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.

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"Scientists, clinicians, device developers, and regulators play critical roles in understanding the operation of medical devices and the associated benefits and risks," the FDA said in its meeting notice. "But only patients live with their medical conditions and need to make the choices required for their care."

The agency aims to use the information gathered from its patient perspectives initiative to influence the broader life-cycle of medical devices, including device innovation and postmarket studies. The FDA is looking for insight into how best to identify patients and their preferences, tools to use when gathering data, how to validate the information and how to then incorporate those lessons into the review cycle.