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  1. CDRH Reports

CDRH 2024 Annual Report

Graphic: Cover of CDRH 2024 Annual Report

Read the Report

Each year, the FDA’s Center for Devices and Radiological Health (CDRH) publishes an Annual Report to highlight programmatic accomplishments and notable updates. The 2024 Annual Report captures CDRH’s work related to novel medical device authorizations, patient-centered initiatives, medical device safety and effectiveness, innovation, supply chain resilience, cybersecurity, digital health, and more.

Some of CDRH’s accomplishments in 2024 included:

  • Advancing innovative, safe, and effective medical device sterilization efforts.
  • Increasing the number of novel device authorizations.
  • Launching Home as a Health Care Hub, a new initiative aimed at reimagining the home environment as an integral part of the health care system and how the home can integrate medical devices in health care, wellness, and evidence generation. 
  • Enhancing the Medical Device Recall Program by increasing transparency and overall timeliness of communications.
  • Ensuring the safety of devices by addressing data integrity issues coming from foreign countries.
  • Taking action to prevent and mitigate supply chain interruptions and to promote resiliency in the U.S. medical supply chain.
  • Publishing a Five-Year Financial Plan and FY24 Update for the Medical Device User Fee Amendments (MDUFA) V.
  • Enhancing the Accreditation Scheme for Conformity Assessment (ASCA) program and publishing revised draft guidance documents.
  • Expanding our Submission Progress Tracking System in the CDRH Portal to include Premarket Authorizations (PMAs).
  • Chairing the International Medical Device Regulators Forum (IMDRF) and hosting two of the organization’s largest meetings.
  • Reducing barriers and increasing opportunities for participation by diverse populations in evidence generation, including traditional clinical trials and real-world data studies.
     
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