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

This article was originally published in SRA

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) program1,2. 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.

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