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

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 FDA to review, on a regular schedule, class I and...