CDRH 2021 Annual Report

The past year presented the U.S and the world with an extraordinary set of health-related challenges. The Center for Devices and Radiological Health (CDRH) and all of the U.S. Food and Drug Administration (FDA) stepped up to shoulder our responsibilities for addressing these unique challenges—all while working hard to keep up with our ongoing mission of protecting public health and spurring medical device innovation.

To highlight this work, CDRH released its 2021 Annual Report, which outlines the Center's programmatic accomplishments through December 2021, including the COVID-19 response, patient science and engagement, device safety, device innovation, and customer service.

Read the Report (PDF - 4 MB)

Topics covered in the report include:

• COVID-19 Response
  • OTC COVID-19 Tests
  • COVID-19 Communication and Engagement
  • Resilient Medical Device Supply Chain
  • CDRH Pandemic Response
  • COVID-19 Postmarket Actions
• Patient Science and Engagement
  • Collaborative Communities
• Device Safety
  • Medical Device Safety Action Plan
  • Material Safety
  • Cybersecurity
  • Quality and Compliance Initiatives
  • Real-World Evidence
• Device Innovation
  • Novel Devices
  • Breakthrough Designation
  • Samples of Novel Breakthroughs
  • Breakthrough Devices in Action
  • Digital Transformation
  • Digital Health
  • OTC Hearing Aid Rule
  • Regulatory Science Tools
• Customer Service