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.
You may also be interested in...
FDA Looks To Expand Special 510(k) Program
US FDA released a draft guidance on the special 510(k) program in an effort to expand and improve the pathway.
Editors' Picks: Six Themes From 2014
Industry closely scrutinized FDA's premarket review performance as the agency took steps to streamline reviews and remake the U.S. postmarket surveillance system. Meanwhile: device mega-mergers accelerated; one of the most hotly anticipated medtech innovations faltered; and national elections swept in Republican control of Congress. Here is a look back at coverage and analysis from "The Gray Sheet" on six key themes for the medical device and diagnostics industry in 2014.
510(k) Data Debated In Comments On FDA Draft Guidance
Device companies say non-clinical data should be given more prominence in FDA guidance on benefit-risk factors to consider when determining substantial equivalence of 510(k) devices with different technological characteristics from a predicate. But a coalition of consumer groups argues that the draft guidance underplays the need for clinical data.