In an eagerly awaited report, the Institute of Medicine (IOM) said today that thousands of medical devices cleared every year for sale are not assessed for safety and effectiveness, and that the clearance process should be abandoned.
The report criticized the 35-year-old 510(k) process that the US Food and Drug Administration (FDA) uses to allow low- to moderate-risk devices—everything from tongue depressors to heart valves and hip implants—to be sold and used in patient care. The process has come under fire in recent years from consumers, physicians, and industry officials. They’ve contended that it overlooks safety and efficacy and is an unpredictable, inconsistent regulatory pathway.
In January the FDA announced some of its own changes to the 510(k) program but asked the IOM to study whether the program provides optimal protection for patients and spurs innovation—and if it doesn’t, how to improve the program.
David Challoner, MD, chair of the 12-member committee that developed the report, said the 510(k) process is “fundamentally flawed” because medical device clearance is based on being “substantially equivalent” to devices already on the market. “Safety and efficacy data are not looked at,” he said during a briefing. The report recommended that FDA officials gather data to devise a new system that would focus on safety and efficacy evaluations before and after products come to market. Congressional approval may be needed to implement a new program.
The FDA responded by announcing that it would accept public comments on the new report. “FDA believes that the 510(k) process should not be eliminated, but we are open to additional proposals and approaches for continued improvement of our device review programs,” said Jeffrey Shuren, MD, director of the agency’s Center for Devices and Radiological Health, in a statement.
The Advanced Medical Technology Association, which represents device makers, took a harder line, saying in a statement that scrapping the 510(k) program for a new, unproven system “would be a disservice to patients and the public health.”
Categories: Public Health