September 24, 2015 — The U.S. Food and Drug Administration (FDA) announced it is establishing an advisory committee focused on patient engagement. The Patient Engagement Advisory Committee will provide advice on complex issues relating to medical devices, the regulation of devices and their use by patients to the FDA Commissioner.
The FDA’s Center for Devices and Radiological Health (CDRH) will lead development of the committee, focusing on including the views of patients during the medical device development process and considering patient perspectives in regulatory decision-making. CDRH engages patients throughout the regulatory process who are interested in contributing their views, data and resources to increase early access to high-quality safe and effective medical devices, reduce adverse events, and improve communication about the risks and benefits that matter most to them.
Part of the FDA’s public health mission is to help patients be more aware of the healthcare options available to them. Alongside industry, patient groups, and other government agencies, the agency is actively engaging individual patients to help them understand how a disease or condition impacts their daily lives and their caregiver’s lives, and the types of treatment benefits and risks that matter the most to them.
Together with other centers and offices across the FDA, CDRH is testing and developing other ways to engage patients and capture their views through public workshops. The center hosted a Patient Preference Initiative Workshop and participated in the Center for Drug Evaluation and Research’s (CDER) patient-focused drug development meetings, which can help inform the FDA staff as they conduct benefit-risk assessments for products under review and advise drug sponsors on their drug development programs.
In addition, CDRH is a member of the Medical Device Innovation Consortium (MDIC), a nonprofit public-private partnership including National Institutes of Health, Centers for Medicare & Medicaid Services, Patient Centered Outcomes Research Institute (PCORI), medical device companies and trade associations, patient groups and other nonprofit organizations. In 2015, MDIC developed a framework for incorporating patient preferences into the device development and assessment process that can be used to develop, design and market devices that meet the needs of patients.
The Patient Engagement Advisory Committee will bring patients, patient advocacy groups and experts together for a broader discussion of important patient-related issues. Such discussions may help inform device innovation, development, evaluation and access and help the FDA meet its public health commitment to improve patients’ health and quality of life.
For more information: www.fda.gov