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FDA CDRH Issues Annual Report
Per the notice below, the United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has issued its annual report for 2024.
The 2024 Annual Report illustrates the many ways CDRH continues to advance safe, effective, and high-quality medical devices and radiation-emitting products. In 2024, we took significant actions to protect and promote the public health and improve device safety, while fostering the development of medical devices that address unmet needs and provide a significant benefit to patients in the U.S. Some of CDRH’s accomplishments in 2024 included:
- Advancing innovative, safe, and effective medical device sterilization efforts.
- Increasing the number of novel medical 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- Enhancing the Accreditation Scheme for Conformity Assessment (ASCA) program and publishing revised draft guidance documents.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 approvals (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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