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Markey Bill Would Bar 510(k) Clearances Of Devices With Recalled Predicates

Sponsors say the bill “closes a significant loophole that currently puts patients at serious risk of debilitating injury by ensuring that devices do not mimic the mistakes made by other products.”

Device makers would no longer be able to claim as predicates for 510(k) submissions devices that have been recalled or are being removed from the market, according to a bill introduced by House Democrats Feb. 1.

The lead sponsor of the bill, Rep. Ed Markey, D-Mass., says the Safety of Untested New Devices Act “closes a significant loophole that currently puts patients at serious risk of...

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