FDA Report Details How Agency Made Medical Devices Safer in 2023

Federal health regulators say they improved medical device safety in 2023, overseeing safety compliance for more than 257,000 devices and improving recalls, among other steps, according to a new report. However, a series of further enhancements are planned throughout 2024, to make devices even more safe for patients.

The U.S. Food and Drug Administration (FDA) released the 2024 Center for Devices and Radiological Health (CDRH) Safety Report on April 17, which highlights progress the agency made over the past year in helping to make medical devices safer for the American public, and outlines 2024 plans, including improved safety programs, removing harmful devices from the market, and improving postmarked surveillance.

Medical Device Quality Improvements

According to the report, one area of focus for the FDA last year was enhancing manufacturing quality. The FDA launched the Case for Quality Program, which focused on improving regulatory compliance for medical device quality and safety. This included enforcing compliance among more than 257,000 manufacturers.

Under the quality program, more than 100 facilities enrolled in the Voluntary Improvement Program. This led to participating manufacturers seeing a downward trend in the number of recalled medical devices.

The effort also included developing the Medical Device Single Audit Program (MDSAP), which created a single regulatory audit of medical devices. More than 6,900 manufacturers participated in this program, and more than 23,000 audits were conducted from 2018 to 2023.

Additionally, the agency launched the Advanced Manufacturing Initiative with the Medical Device Innovation Consortium to evaluate advanced design and manufacturing technology.

Post-Marketing Surveillance

Under the National Evaluation System for Health Technology, the agency established a network of 266 hospitals and medical centers and 22,000 specialty clinic collaborators, providing access to 161 million records to assist in post-marketing surveillance efforts.

Additionally, the agency continued developing the Unique Device Identifier System, which includes data for more than 4.34 million devices. As of last year, roughly 80% of all medical device reports display unique device identification, allowing for better tracking and execution of recalls when safety concerns emerge.

The FDA report also indicated the agency initiated 36 post-marked studies on high-priority device areas, including pulse oximeters, breast implants, and other medical devices.

Pulse oximeters gained media attention in the past few years, following studies suggesting they may not accurately read the pulse of minorities and people with darker skin tones. As a result, the FDA held an advisory committee meeting on pulse oximeters earlier this year to focus on improving their performance.

Medical Device Recalls

The other pillars of FDA improvement, according to the report, are improved communication and data transparency around medical device safety and strengthened recall programs.

The FDA worked to issue guidance on recalls, improve the benefit-risk decision-making process, provide public access to recall data, and introduce a template for recall review, according to the report.

Additionally, the report indicates that the FDA focused on medical device safety action plans, established the active surveillance system, enhanced post-market research, launched programs to develop innovative device technology, and improved device cybersecurity.

The FDA notes that plans for 2024 include further improvements to medical device quality, strengthen surveillance, and further enhancements to the medical device recall program.

“Medical device safety is a top priority for CDRH,” the FDA report states. “We will continue working to assure the U.S. is among the first to detect and address safety signals, working closely with our domestic and international partners to help ensure patients can depend on the devices CDRH approves, clears, and authorizes for marketing.”