2024 CDRH Safety Report  

The FDA Center for Devices and Regulatory Health issued its CDRH 2024 Safety Report on April 17, 2024. The report outlines the commitment of the Center for Devices and Radiological Health (CDRH) to ensuring the safety and effectiveness of medical devices throughout their lifecycle. 

And as the report cover states, “CDRH is committed to advancing the core pillars of medical device safety and innovation to protect, promote, and encourage public health for all.” 

The report emphasizes the importance of maintaining a balance between innovation and safety, highlighting the need for regulatory decisions that prioritize patient well-being. 

Key areas of focus include: 

Enhance Manufacturing Quality 

CDRH prioritizes the design and manufacture of high-quality devices to protect public health. They work closely with manufacturers to prevent problems and address safety issues promptly. 

Strengthen Postmarket Surveillance 

CDRH has implemented improvements to its postmarket surveillance activities, including monitoring adverse events, conducting FDA-mandated studies, and establishing signal management programs to identify and address safety concerns. 

Increase Data Transparency, Communication, and Collaboration 

CDRH works to expand capabilities and create new programs to share information about safety signals and coordinate actions to address them globally. 

Strengthen Medical Device Recall Program 

CDRH has issued guidance documents to help manufacturers ensure device safety and engage with industry to improve recall processes and protect public health. 

Execute Medical Device Safety Action Plan 

CDRH is committed to implementing the Medical Device Safety Action Plan issued in 2018, which aims to enhance programs and processes to assure device safety throughout the Total Product Life Cycle. 

Moving forward 

CDRH plans to take further actions in 2024 to ensure devices on the U.S. market are high-quality, safe, and effective. They emphasize collaboration with domestic and international partners to detect and address safety issues promptly, prioritize public health outcomes, and take regulatory or enforcement actions when necessary. 

Links 

Read the 2024 CDRH Safety Report here. 

Read about the 2024 CDRH Innovation Report here.