CDRH 2022 Annual Report Now Available: The report highlights the Pandemic Response, MDUFA V Accomplishments, Device Safety, OTC Hearing Aid Final Rule, and Device Innovation.
Jeff Shuren, M.D., J.D.
Director, Center for Devices
and Radiological Health
Who We Are
CDRH's Office of the Center Director (OCD) provides vision, leadership and strategic direction for the Center.
What We Do
- Provide vision, leadership, and strategic direction for the Center regarding the regulation of medical devices and radiation-emitting products.
- Provide leadership and direction for Center-level management, planning, and evaluation systems to ensure optimal utilization of personnel, budgetary and financial resources.
International Affairs Program
- Provide vison, leadership and strategic direction for the Center regarding engagement with international regulatory authorities to promote alignment in regulatory requirements.
- Engage with international regulatory authorities to implement policies and programs such as the Medical Device Single Audit Program (MDSAP) that align standards and regulations for medical devices.
- Participate in medical device regulatory harmonization initiatives including the International Medical Device Regulators Forum (IMDRF).
Quality Management Staff
- Provide vison, leadership and strategic direction for the Center regarding quality management, and organizational excellence.
- Establish and develop resources to facilitate implementation of quality management and organizational excellence for CDRH.
- Integrate applicable quality management and organizational excellence principles and best practices into key business processes.
- Establish a foundation for quality, effectiveness, efficiency, and improvement for all products, services and business processes.
- Support CDRH's mission to achieve organizational excellence, efficiency and effectiveness while delivering continually improved products and services to provide the public access to safe, effective and high quality medical devices and safe radiation-emitting products.
- Office of the Center Director
- CDRH International Programs
- Quality Management Staff
For specific phone numbers and email addresses for each office, division, and branch, see the CDRH Management Directory by Organization.