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FDA to overhaul more than 40-year-old process for approving medical devices amid scrutiny

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FDA to overhaul more than 40-year-old process for approving medical devices amid scrutiny
In modernizing the 510(k) approval process, the FDA wants medical device manufacturers to base new products on devices that are no older than 10 years old. Currently, companies can compare new devices to technology that's about 40 years old.
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5 years ago

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