The FDA has decided to keep its Patient Engagement Advisory Committee going for two more years, extending the expert group’s charter to Oct. 6, 2021.
The nine-member committee provides the agency advice on medical device-related topics, including clinical trial designs, benefit-risk determinations, labeling, real-world data and unmet clinical needs, among others.
The advisory committee met in 2019 to consider how to communicate medical device cybersecurity risks to patients and the public.
Patient engagement has become an increasing focus for the FDA in the past decade. It began to embrace patient-centered care in 2011. By January 2018, 80 percent of agency-approved trials included patient-reported health outcomes, according to Center for Devices and Radiological Health Director Jeff Shuren.