Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions
This article was originally published in The Gray Sheet
New concepts such as “primary predicates” and “reference devices” may be more confusing than clarifying, former FDA staffers say.
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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.
CDRH says it plans to release the 510(k) program final guidance as well as the anticipated in vitro companion diagnostic final guidance next year. The device center has divided the 22 forthcoming guidance documents into an “A-list” and a “B-list,” based on its priorities and allocated resources.
Flaws in the 510(k) process prevented FDA from noticing high metal-on-metal revision rates, researchers write in the New England Journal of Medicine. Their argument is based on a predicate “ancestry” analysis of DePuy’s recalled ASR hip system.