Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria (Draft Guidance — April 2018)

Note: The FDA issued a final version of this guidance, "Safety and Performance Based Pathway," on Jan. 22, 2019.

This guidance provides FDA’s current thinking on expanding the use of the Abbreviated 510(k) program for demonstrating substantial equivalence for premarket notification (510(k)) submissions. The intent of the guidance is to describe an optional pathway for certain, well understood device types, where a submitter would demonstrate that a new device meets FDA identified performance criteria to demonstrate that the device is as safe and effective as a legally marketed device.