Department of Health and Human Services February 1, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Safety and Performance Based Pathway,'' which was previously issued in draft version entitled ``Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence Through Performance Criteria.'' This final guidance provides FDA's current thinking on using performance criteria to demonstrate substantial equivalence for premarket notification (510(k)) submissions. The intent of the final guidance is to describe an optional program for certain well understood device types, where a submitter could demonstrate that a new device meets FDA-identified performance criteria instead of directly comparing the performance of the new device to a specific, submitter-identified predicate device as part of a demonstration of substantial equivalence.