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FDA To Tighten Norms For Approval Of Medical Devices

by Gopalan on December 31, 2009 at 11:25 AM General Health News

The US Food and Drugs Administration (FDA) is gearing up to tighten the norms for approval of medical devices. The move comes in the backdrop of a couple of studies charging that while the agency pulled out all the stops when dealing with drugs, it allowed the device manufacturers get away lightly.

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One of the articles, published Tuesday in the Journal of the American Medical Association, or JAMA, says many cardiovascular devices are approved based on a single study; whereas most drugs go through several layers of testing.

"The bar for evidence of benefit should be higher for devices because they are implanted and cannot simply be discontinued, as drugs can," the researchers said in the JAMA paper.

The other study, published in the American Journal of Therapeutics, included as an author a medical reviewer in the FDA's cardiovascular device division. The authors concluded that studies submitted to get a cardiovascular device approved "frequently lack important details" such as information about the people used in research.

The researchers for both articles looked at about 80 cardiovascular devices that were approved from 2000 through 2007. The JAMA article, by researchers at the University of California, San Francisco, was based on publicly available FDA summaries of the safety and effectiveness of the devices.

Most of the approvals were based on a single study. Less than a third of the studies were randomized. And only about half of the primary measures in the studies were compared with outcomes from control groups. The authors, based at UC San Francisco, found that FDA approval was �often based on studies that lack adequate strength and may be prone to bias.�

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FDA To Tighten Norms For Approval Of Medical Devices

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