US FDA says use of spilt predicates is inconsistent with 510(k) device programme
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has issued draft guidance explaining the critical aspects of its pre-market notification, or 510(k), programme under which it clears medium- to low-risk medical devices if they are found to be "substantially equivalent" to a previous legally marketed device (also known as a predicate device)1,2. The document explains how the agency makes substantial equivalence determinations.