Class II Category Based On "Safety And Performance" Still Priority For CDRH
This article was originally published in The Gray Sheet
Amending the Class II device definition to require demonstration of "safety and performance" rather than substantial equivalence is high on the FDA Center for Devices and Radiological Health's list of priorities for discussion during the first round of renegotiation of the FDA Modernization Act, according to topsiders at the device center.
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