The FDA’s Patient Engagement Advisory Committee (PEAC) will hold its inaugural meeting in Gaithersburg, Maryland, October 11-12 to discuss how patients, devicemakers, and the FDA can share information.
The nine-member committee will meet “once or twice a year,” the agency says, and the meetings will be open to the public.
Patients can have “unexpected experiences” with a device or clinical trial, and the PEAC will allow patients to share what happened with the device manufacturer and the FDA, said Jeffrey Shuren, CDRH director, and Kathryn O’Callaghan, CDRH assistant director for strategic programs, in a July 25 blog post.
The committee will consider how patients can provide input across the medical device lifecycle, and how to get patient input related to medical device performance once products are on the market.
The PEAC is a response to 2012 federal legislation that instructed the FDA to “solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussion.”
The legislation led directly to the formation of the PEAC, though it is not the only forum involving patients that has been created because of the legislation. Last year alone, CDRH “held 21 patient interaction opportunities, involving 34 patient organizations with 68 percent of CDRH staff interacting with patients,” and agency spokesperson said.
The agency is also working to ensure that patient perspective is considered in the evaluation of medical devices beyond the confines of PEAC. The number of approved investigational device exemptions, for example, has included patient reported outcomes 65 percent of the time. — Donna Scaramastra Gorman