June 27, 2019
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The controversial FDA clearance process known as 510(k) Premarket Notification is a prime example of the law of unintended consequences. In the 1970s, this provision became law with the purpose of making life-saving medical devices available to patients in the shortest possible time. Instead, it has in many cases given medical device manufacturers the ability to bring untested, dangerous and, in many cases, deadly health care products to the market, foisting them onto an unsuspecting public, including doctors and health care providers. But it appears that after huge public backlash, the FDA might FINALLY be reevaluating their process. Ring of Fire’s Farron Cousins discusses this with Scott Hardy from Top Class Actions.
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