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Why Did Harmful Medical Devices Get Easy FDA Approval?

A recent analysis has shown that most medical devices recalled in recent years because of life-threatening problems were cleared for approval under loose regulations that don't require human testing.

The FDA is currently reviewing sweeping proposals to revise the medical device approval process. Many recalled devices fell under rules for products similar to ones on the market; regulations for entirely new products call for more extensive testing.

Time Magazine reports:

"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 ... Of the 113 highest-risk recalled devices, 71 percent, or 80 devices, had been approved through the less stringent regulation."

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