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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.

The notice was triggered by the 21st Century Cures Act, enacted last December, which included a provision directing...

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