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 2023 was a transformative year at the FDA’s Center for Devices and Radiological Health (CDRH). The Center officially turned a corner on the COVID-19 pandemic and moved toward a more sustainable workload, including prioritizing normal review timelines for all incoming premarket submissions. In 2023, CDRH authorized the highest number of novel medical devices on record (excluding EUAs).
In addition to highlighting medical device authorizations, the 2023 Annual Report illustrates the many ways CDRH continues to advance innovation and ensure people have access to safe, effective, and high-quality medical devices and radiation-emitting products. Some of CDRH’s accomplishments in 2023 included:
- Expediting premarket submissions through the Breakthrough Devices Program.
- Launching the Total Product Life Cycle Advisory Program (TAP) Pilot to spur rapid development of safe, effective medical devices that are critical to public health.
- Implementing process improvements to the Medical Device User Fee Amendments (MDUFA V) to include international regulatory harmonization, third-party review, and programmatic guidance development.
- Working to prevent and mitigate medical device shortages to assure patients have access to critical life-saving and life-supporting devices.
- Advancing digital health innovation by exploring emerging technologies, such as artificial intelligence and machine learning-enabled (AI/ML) medical devices.
- Ensuring technology is designed and targeted to meet the needs of diverse populations to advance health equity.
- Publishing final guidances about key cybersecurity topics to help mitigate potential risks that the medical device industry faces as it becomes increasingly integrated with digital components. CDRH also spearheaded international medical device cybersecurity risk management efforts and marked the 10-year anniversary of CDRH’s Cybersecurity Program.
- Strengthening the fight against breast cancer by modernizing mammography regulations under the Mammography Quality Standards Act (MQSA).
- Issuing a proposed rule aimed at helping to ensure the safety and effectiveness of laboratory developed tests (LDTs).
- Enhancing hiring practices and improving employee wellness programs.
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