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FDA's 510(k) process puts dangerous devices on the market, study says

In an analysis of more than 100 high-risk medical device recalls, the authors of a new study published in the Archives of Internal Medicine found that 71 percent had been approved through the FDA’s less-rigorous 510(k) process. The study “will help to establish that 510(k) is not an FDA approval process—it's a free pass, and it regularly results in bad devices reaching patients,” said one plaintiff attorney.

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