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FDA Modernizes Medical Device 510(k) Approval Program

Nov. 26, 2018, 5:06 PM

The FDA is making changes to modernize its 510(k) medical device clearance pathway that accounts for the majority of devices the agency reviews.

The changes are to keep pace with the complexity of evolving technology, Commissioner Scott Gottlieb and Director of the Center for Devices and Radiological Health Jeff Shuren said Nov. 26 in a statement announcing the change.

The Food and Drug Administration will promote the use of more recent predicates when manufacturers reply on comparative testing against a predicate device.

The CDRH is considering making public on its website those cleared devices that demonstrated substantial equivalence to older...

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