FDA Announcement on New Patient Engagement Initiative
Today the FDA is announcing the establishment of the Patient Engagement Advisory Committee (PEAC) to help assure that the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues relating to the regulation of medical devices and their use by patients.
While patient representatives participate in many FDA advisory committee meetings, the FDA has never had a committee that was wholly focused on patients. Rather than focusing on a product or specific disease, the new committee will be asked to weigh in on a variety of important patient-related issues. The FDA is asking the public to comment on which issues the committee should focus on first.
The FDA is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. For information about how to nominate yourself or another candidate to participate in the Committee please see the Federal Register notice.
For more information about additional ways that CDRH is engaging patients, see the CDRH Patient Engagement webpage.
For more information about the Patient Engagement Advisory Committee, see the Patient Engagement Advisory Committee webpage.
Thank you,
Food and Drug Administration
Center for Devices and Radiological Health
Filed under: Advocacy, FDA, Local Press, Patent Foramen Ovale, PFO, PFO Closure, PFO Research Tagged: David Dansereau, FDA, know-stroke.org, patient engagement, Patient Engagement Advisory Committee
