The Committee will provide advice to the Commissioner or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients.
The Committee may consider topics 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.
The Committee will provide relevant skills and perspectives, in order to improve communication of benefits, risks, clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices.
It will perform its duties by discussing and providing advice and recommendation in ways such as:
- Identifying new approaches,
- Promoting innovation,
- Recognizing unforeseen risks or barriers, and
- Identifying unintended consequences that could result from FDA policy