FDA is urged to revamp its review process for medical devices


The Food and Drug Administration should stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness, the National Academy of Sciences said Friday.

The academy’s report, coming after a spate of recalls and problems with such devices, pointed up a little-known quirk in the law. In theory, the FDA has broad responsibility to ensure that drugs and medical devices are safe and effective. But thousands of devices go through an expedited review because they are considered similar to older devices that are already on the market.

In its report released Friday, the Institute of Medicine, an arm of the National Academy of Sciences, recommended that the system be abolished and new procedures established.


“It’s not clear that the … process is serving the needs of either industry or patients, and simply modifying it again will not help,” David Challoner, chairman of the committee that wrote the report, said in a statement.

The FDA disputed the institute’s conclusions, even though it had asked for the analysis.

Medical devices range from simple adhesive strip bandages used for minor cuts to contact lenses and pacemakers. When they fail, they can generate health problems and healthcare costs, even imperil lives.

The present system requires that all medical devices go through the FDA before they can be marketed, but the vast majority can be cleared for sale without clinical evaluation.

When the FDA was given responsibility for medical devices in 1976, Congress specified that those already on the market could continue to be sold without testing.

At the same time, Congress created the so-called 510(k) process under which new devices could be cleared for market if they were “substantially equivalent” to existing products.

The result was that the vast majority got FDA clearance based on older devices that were never subjected to the rigorous pre-market testing required for pharmaceuticals.


Devices approved in the expedited process are more likely to be recalled, studies have found.

More than 90,000 artificial hips were recalled last summer after studies showed that about 1 in 8 recipients needed to have them replaced. The hips, manufactured by a subsidiary of Johnson & Johnson, were found to release small metallic particles into patients’ bloodstreams over time.

In 2009, the Institute of Medicine’s report noted, about 4,000 medical devices were cleared under the expedited 510(k) process — more than 90% of all devices subject to FDA clearance. Simple “devices” such as tongue depressors and adhesive strips can be sold without FDA clearance, although companies must notify the agency.

Critics contend that the 510(k) process amounts to a loophole for marketing products without adequate attention to safety or effectiveness.

In particular, a 2009 report by the Government Accountability Office found that the FDA had failed to perform stricter reviews on more than two dozen categories of medical devices, as Congress had directed the agency to do in 1990.

The 1990 legislation did not set a deadline for the more rigorous reviews. This year, the FDA promised to complete the task by the end of 2012.


Bowing to pressure from the GAO and consumer groups, the FDA initiated two internal reviews of the process in 2009. This year, it outlined 25 changes it planned to make, including streamlining the review of lower-risk devices.

The FDA also asked the Institute of Medicine to perform the evaluation that resulted in Friday’s report, but rejected its principal finding.

“FDA believes that the 510(k) process should not be eliminated,” Dr. Jeffrey Shuren, director of the agency’s medical devices arm, said in a statement. “But we are open to additional proposals and approaches for continued improvement of our device-review programs.”

Device manufacturers contend that the 510(k) process slows the flow of new products to market.

“It is not technology, science, ingenuity or the economy that is standing in the way of success in developing new medical technologies. In my opinion, it is today the FDA,” engineer Robert Fischell told a subcommittee of the House Energy and Commerce Committee last week.

Fischell, inventor of an implantable insulin pump and a series of coronary stents, said that the medical device approval process was inconsistent and that the FDA staff was not sufficiently trained.


“Beyond the adverse impact FDA is having on patient care, it’s weakening the U.S. leadership position in medical technology innovation and, as a result, hurting our economy,” he told Congress.