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FDA 510(k)-Exempts 72 Devices, Mostly Diagnostics

 
• By David Filmore

The US agency has exempted 72 different class I device types from the 510(k) requirement, effective April 13, using a procedure laid out by the 21st Century Cures Act. A majority of the products are in vitro diagnostics and reagents, but there also devices such as patient beds, restraints and first-aid kits.

A US FDA notice scheduled for publication April 13 will formally exempt 72 device-types from the 510(k)-submission requirement. The devices were already designated as low-risk, class I devices, but still technically subject to pre-market review. That requirement has now been removed, though quality and registration mandates remain in place.

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