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FDA Proposes New Way To Approve Updated Medical Devices

Friday, April 13, 2018   (0 Comments)
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Law360 (April 12, 2018, 4:04 PM EDT) -- The U.S. Food and Drug Administration on Wednesday released anticipated proposed draft guidance laying out an alternative pathway for medical device manufacturers to prove that their new devices are as safe and effective as ones already on the market.

As it stands now, medical device manufacturers have to prove that their devices hold up to already approved ones, even if those pre-existing devices are decades old. The new alternative, which is voluntary, would let manufacturers rely on objective safety and effectiveness criteria to prove that their...


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