In a 280-page report released today, the Institute of Medicine harshly criticized the way medical devices — such as pacemakers, magnetic resonance imaging machines, and heart-lung machines — are reviewed for safety and effectiveness before being brought to market. The process used by the US Food and Drug Administration, the committee of specialists said, “is not a determination that the cleared device is safe or effective’’ and “lacks the legal basis to be a reliable premarket screen.’’
The solution, said the panel, is to scrap the program — called 510(k) — and create a new one that incorporates better surveillance of safety and performance after a device hits the market. For example, the FDA rarely uses enforcement tools such as seizing or banning an unsafe device because the agency said it is limited in how it can exert its authority, according to the report.
“It’s not clear that the 510(k) process is serving the needs of either industry or patients, and simply modifying it again will not help,’’ said committee chairman David Challoner of the University of Florida in a statement. “The 510(k) process cannot achieve its stated goals — to promote innovation and make safe, effective devices available to patients in a timely manner — because they are fundamentally at odds with the statutes that govern how FDA must implement the process.’’
The FDA said it will take public comments on the institute’s report, which the agency itself commissioned two years ago, but added that the recommendations aren’t binding.
“We appreciate the IOM’s report on the 510(k) program,’’ said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health in a statement. “Medical devices in the US have a strong track record of safety and effectiveness. The 510(k) program has helped … bring lower-risk devices to market for the patients who need them.’’
He added that the FDA doesn’t plan to eliminate the program but that it would continue to look for ways to improve how it reviews and monitors devices.