On September 28, 2018, the U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance document, entitled "The Special 510(k) Program," which, when finalized, will supersede the currently in effect Special 510(k) policy outlined in "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence" (March 20, 1998).
Please see full publication below for more information.