In the March 21, 2016, Federal Register, FDA issued a final rule amending the standing advisory committees' regulations to add the Patient Engagement Advisory Committee (the "Committee"). The Committee was established on October 6, 2015, and will provide advice to the FDA Commissioner on complex issues relating to medical devices, regulation of devices, and device use by patients. Topics the Committee will consider include 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. The rule was effective March 21, 2016.
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