In an effort to further involve patients in the medical device
development process, FDA's Center for Devices and Radiological
Health recently announced it will form a new Patient Engagement Advisory Committee
("PEAC"). The committee will consist of nine voting
members, one consumer representative, and, depending on the meeting
topic, a varying number of temporary nonvoting members selected
from a pool of industry-nominated individuals. The committee will
advise FDA on issues such as agency guidance and policies, clinical
trial or registry design, patient preference study design,
benefit–risk determinations, device labeling, unmet clinical
needs, available alternatives, patient-reported outcomes and
device-related quality of life or health status issues, and other
patient-related topics.
According to FDA, discussions with PEAC may help the agency
"meet its public health commitment to improve patients'
health and quality of life." The committee is accepting the
first set of nominations through November 20, 2015 (later
nominations will be considered as vacancies occur). Statements of
interest and nominations may be submitted through October 21,
2015.
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