FDA considers patient preference on benefit-risk trade-offs in 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.

"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.

The FDA will solicit public comments during a workshop entitled "The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes." The meeting will be held on Sept. 18 and 19, 2013, from 8 a.m. to 5 p.m. at the FDA’s White Oak Campus in Maryland. The workshop will also be streamed live via the web, but interested participants must sign up via the agency’s online registration form.

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