In a report initially commissioned by the Food and Drug Administration, a 12 member panel of medical experts from the Institute of Medicine has recommended the U.S. government retire the 35-year-old system currently used to approve medical devices because it provides little or no assurance of safety for patients.
The FDA was originally given responsibility for medical devices in 1976, at the time Congress specified that those already on the market could continue to be sold without testing.
Congress then developed the so-called 510(k) process under which new devices could be cleared for market if they were “substantially equivalent” to existing products.
Consequently, thousands of medical devices have received FDA clearance based on older devices, none of which were subjected to the kinds of rigorous pre-market testing required for pharmaceuticals.
Medical devices can range from simple adhesive strip bandages used for minor cuts to contact lenses and pacemakers. When the more complex devices fail, they can cause health problems and incur health-care costs, possibly even imperil lives.
The IMO panel’s advice is not binding. But it could signal a new era of tighter standards for medical device manufacturers, a $350 billion industry, who have long benefited from less safety scrutiny than their peers in the drug industry.
The report released on Friday was met with resistance from the FDA.
“FDA believes that the 510(k) process should not be eliminated,” Dr. Jeffery Shuren, director of the agency’s medical devices arm, said in a statement about the new report. “But we are open to additional proposals and approaches for continued improvement of our device-review programs.”