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Paradigm Persists: FDA Finalizes 510(k) Guidance Without Special 510(k) Changes

This article was originally published in The Gray Sheet

Executive Summary

FDA has finalized an important guidance on 510(k) substantial equivalence, but decided to hold off on including sections that would overwrite the popular 1998 “The New 510(k) Paradigm” guidance that describe the abridged special and abbreviated 510(k) routes. Industry strongly objected to FDA’s proposed changes to the special 510(k) program in the 2011 draft 510(k) guidance.

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