CDRH Mission, Vision and Shared Values
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.
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world. The U.S. is the world’s leader in regulatory science, medical device innovation and manufacturing, and radiation-emitting product safety. U.S. post-market surveillance quickly identifies poorly performing devices, accurately characterizes real-world performance, and facilitates device approval or clearance. Devices are legally marketed in the U.S. and remain safe, effective, and of high-quality. Consumers, patients, their caregivers, and providers have access to understandable science-based information about medical devices and use this information to make health care decisions.
- Public Health Focus - We focus on activities and outcomes that protect and promote public health.
- Science-Based Decisions - We make decisions based on sound science using the best available data, methods, information, and tools. We value and take into account differing internal and external perspectives.
- Our People - Our staff is our most critical resource. We value individual excellence, teamwork, and personal and professional diversity.
- Innovation - We challenge the status quo and ourselves to foster positive change. We harness the creativity of our staff and stakeholders. We rapidly test and adopt new approaches to more effectively and efficiently accomplish our mission.
- Transparency - We foster public trust and predictability by providing meaningful and timely information about the products we regulate and the decisions we make.
- Honesty and Integrity - We maintain the public trust by acting with integrity and honesty. Our actions adhere to the highest ethical standards and the law.
- Accountability - We hold ourselves accountable for the actions we do and do not take. We acknowledge our errors and learn from them.