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  1. CDRH Reports

CDRH 2022 Annual Report

CDRH 2022 Annual Report Feature

The FDA’s Center for Devices and Radiological Health (CDRH) released its 2022 Annual Report to highlight the Center’s programmatic accomplishments through December 31, 2022, including the Pandemic Response, the Medical Device User Fee Amendment (MDUFA) V, Device Innovation, Over-the-Counter (OTC) Hearing Aid Final Rule, and Device Safety.

Read the Report (PDF - 11MB)

Topics covered in the report include:

  • CDRH By the Numbers
  • Pandemic Response
    • COVID-19
    • Mpox
  • Device Innovation
    • Novel Devices
    • Upstream Innovation
    • Expediting Premarket Submissions
    • Marketing Authorizations for Novel Devices
    • Digital Health
  • OTC Hearing Aid Final Rule
  • Device Safety
    • Recalls
    • Cybersecurity
    • Material Safety
    • Health of Women Strategic Plan
    • Real World Evidence / Real World Data


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