mdi ConsultantsClients are being made aware of this new milestone development for the first time in the FDA’s history, through which FDA 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.
CDRH’s Role in patient engagement:
- The Center for Devices and Radiological Health (CDRH) is committed to including the views of patients during the medical device development process and considering patient perspectives in our regulatory decision-making.
- To better understand their needs, CDRH engages patients throughout our regulatory process.
- Patients 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 CDRH’s public health mission is to help patients be more aware of the health care options available to them.
FDA efforts to engage patients and capture their views:
Together with other centers and offices across the FDA, they are testing and developing other ways to engage patients and capture their views through public workshops. CDRH hosted a Patient Preference Initiative Workshop and participated in CDER’s 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.
Other FDA affiliations to promote and benefit this patient engagement:
In addition, CDRH is a member of the Medical Device Innovation Consortium (MDIC), a non-profit 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 non-profit 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.
I For more information about this new initiative please read CDRH patient engagement