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

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.

FDA has finalized a highly anticipated guidance document on its 510(k) program, but one of the most controversial sections of the 2011 draft version of the guidance, on the “special 510(k)” program, is absent.

The agency elected not to include discussion of special 510(k)s, or the similar abbreviated 510(k) program, in its final guidance,...

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