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 our public health mission is to help patients be more aware of the health care options available to them. Alongside industry, patient groups, and other government agencies, we are 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, we 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.
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. Partner with Patients was one of CDRH's 2016-2017 Strategic Priorities, and more information about its progress is available in CDRH's 2018-2020 strategic priorities.
Resources for You
- Value and Use of Patient-Reported Outcomes (PROs) in Assessing Effects of Medical Devices
- CDRH Patient-Reported Outcomes (PRO) Compendium (XLSX - 115KB)
- FR Notice: The Establishment of the Patient and Care-Partner Connection
- Patient Engagement Advisory Committee
- MDIC Framework Report
- Federal Register: Establishment of the Patient Engagement Advisory Committee
- Federal Register: Nominations for Industry Representative for PEAC
- Federal Register: Nominations for Consumer Representative for PEAC
- Federal Register: Nominations for Committee Members for PEAC