July 29th, 2011

Los Angeles Times reports:

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.

For the rest of the story, read the Los Angeles Times