CHICAGO – Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don't require human testing, an analysis found.
The report comes as the Food and Drug Administration is reviewing sweeping proposals to revise the medical device approval process. The studied devices fell under rules for products similar to ones on the market, not regulations for brand new ones, which call for more extensive testing.
Thousands of deaths or serious medical problems occurred in patients with the recalled devices, which included external heart defibrillators, brain shunts and implanted pumps that deliver cancer drugs, the researchers said.
Device makers say the new data are flawed and conflict with previous reports.
For their analysis, the researchers looked at the FDA's list of high-risk devices that were recalled from 2005 through 2009.
Of the 113 highest-risk recalled devices, 71 percent, or 80 devices, had been approved through the less stringent regulation. Only 19 percent, or 21 devices, were approved under a stricter process for brand new products that involves inspections and human testing. Eight were registered with the FDA but exempt from regulation. . . " Read More
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