Patients will now be a part of device regulation, offering advice on a wide variety of issues.
The Food and Drug Administration has created the Patient Engagement Advisory Committee (PEAC), which will “provide advice to the FDA commissioner on a range of complex issues relating to medical devices, and their use by patients,” according to a Sept. 18 blog post on the FDA website by Nina Hunter, Ph.D., a regulatory scientist in the FDA’s Center for Devices and Radiological Health, and Dr. Robert M. Califf, deputy commissioner for medical products and tobacco, and nominee to take over the agency as commissioner.
Dr. Robert Califf
“Some questions that the PEAC may discuss include where and how best to engage patients across the device development and assessment life cycle as well as how FDA and sponsors should communicate patient preference information to patients,” Dr. Hunter and Dr. Califf wrote.
According to FDA, topics that the committee could consider include agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical need, available alternatives, patient-reported outcomes, and device-related quality of life or health state issues, or other related topics.
The committee will consist of nine voting members who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States, as well as one consumer representative. Nonvoting members representing industry can be added as subject matter warrants.
Dr. Hunter and Dr. Califf were clear that the patient preference information “will not be used to justify approval of unsafe or ineffective devices,” but when the agency is assessing a device for approval, “FDA may consider rigorous, systematically gathered patient preference information as part of the totality of the evidence from clinical and nonclinical testing.