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December 02, 2018 | Tom Ballard

FDA announces plans for better medical device clearance process

The U.S. Food and Drug Administration (FDA) announced plans to implement changes to its medical device clearance process that would rely far less on older predicate devices and offer a modernized pathway for high-tech medical innovations. The changes represent a significant shift in the way the FDA approves devices for marketing in the U.S., a process first introduced more than 40 years ago. Specifically, the agency plans to change the 510(k) pathway required for new medical devices to account for advances in medical technology. Read more here.

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