An artificial heart
The FDA has been urged to adopt new guidelines for medical devices, including everything from contact lenses to artificial hearts. Image from Wikimedia Commons.

A study by the Institute of Medicine, part of the National Institutes of Health, is urging the Food and Drug Administration to revise its approval policies for medical devices. Trade groups attacked the report, which contends that the FDA is too lax in approving what devices can be used in patients.

Fast track approval of medical devices flawed, says study

Trade groups are blasting a study by the Institute of Medicine for bias, according to Reuters. The IOM strongly recommended that the Food and Drug Administration overhaul its medical device fast-track approval process known as 51o(k). Currently, a device maker can apply for 510(k) and get a device approved without having to prove the device is safe in a clinical trial, if the device is similar to another device on the market. About 90 percent of all medical devices, such as artificial hips and pacemakers, are approved using the 510(k) process, according to the Los Angeles Times. There were 4,000 devices approved through 501(k) in 2009.

Trade groups irked over report

Various trade groups and companies took issue with the IOM recommendations. The Advanced Medical Technology Association, or AdvaMed, said that the IOM proposal to do away with 510(k) would be detrimental to businesses and consumers because the IOM didn’t recommend anything to replace it. The Washington Legal Foundation, according to the New York Times, petitioned the FDA last month to not accept any of the IOM’s recommendations. The WLF asserted the panel was biased because the IOM panel that prepared the report did not include a surgeon. The FDA requested the study but stated that it doesn’t have to consider the IOM’s conclusions. Device makers, who produce anything from contact lenses to defibrillators to surgical bandages, insist that creating further obstacles to device approval could be harmful to consumers by keeping new devices off the market. However, studies have shown devices approved through 510(k) are more likely to be recalled than devices that were approved after a full clinical trial.

510(k) results in recalls

Last year, 93,000 hip implants made by Johnson & Johnson were recalled when it was found that metal particles were leaking into patients’ bloodstreams. In 2009, the Government Accountability Office ordered the FDA to shore up the 510(k) program because it allowed easy approval without sufficient proof of product safety. That same year, according to the Wall Street Journal, the FDA gave 510(k) approval to Menaflex, a surgical replacement for the meniscus, the rubber-like lining of the knee between bones. Menaflex never went through a full clinical trial and was rejected twice for 510(k) approval because there was no similar product. ReGen, the company that manufactured it, used lobbyists to get Congress to pressure the FDA to accept Menaflex for 501(k) approval, which the FDA eventually did. Menaflex was later unapproved after it was released, and ReGen went bankrupt.



Los Angeles Times:,0,2107495.story

New York Times:

Wall Street Journal:

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