“The FDA is still letting doctors implant untested devices into our bodies”

That's the name of this Washington Post article by Jeanne Lenzer and Shannon Brownlee. The article explains that the FDA continues to allow critical, implanted medical devices on the market via the so-called "510(k) process." Among other serious deficiencies, the 510(k) process does not require pre-market clinical safety testing. Lenzer and Brownlee explain that the FDA's lax regulation has harmed patients and note that while dangerous devices "have received widespread coverage in the press," that publicity has "had virtually no effect on FDA policy. Even a damning 2011 report by the Institute of Medicine (requested by the FDA), which deemed the agency’s 501(k) pathway so flawed it should be thrown out, fell on deaf ears." 

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