Fierce Healthcare November 26, 2018
Evan Sweeney

FDA Commissioner Scott Gottlieb said the agency is moving forward with changes to modernize the 510(k) process.

The Food and Drug Administration (FDA) is preparing 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, outlined by the agency’s top officials on Monday, 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, FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., director of the...

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