US FDA drops controversial sections from its final 510(k) medtech guidance on substantial equivalence

Executive Summary

The US Food and Drug Administration has finalized much-awaited guidance on how it determines that a medical device is "substantially equivalent" to a previous legally marketed device (also known as a predicate device) under its pre-market notification or 510(k) program^1,2. The most controversial sections in the guidance, on the special and abbreviated 510(k) programs, have been deliberately left out and will be tackled by the agency in a separate document later.