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Regulatory News In Brief

Minnesota device makers petition FDA. Invacare lays off workers following FDA consent decree. More regulatory news.

Law firm DuVal and Associates filed a Citizen Petition with FDA on behalf of the Minnesota Medical Device Alliance Jan. 2, requesting a stay of implementation of the agency's December 2011 draft guidance on substantial equivalence in 510(k) submissions. (See Also see "Changing The Paradigm: 510(k) Draft Guidance May Raise New Questions" - Medtech Insight, 9 January, 2012..) The petition asks FDA to revert to use of the 510(k) guidance documents currently in existence, until the agency has taken steps outlined by the group. The petition details 510(k) review practices in recent years which, MMDA alleges, "have dramatically changed the manner in which the 510(k) program operates."

The petition argues the agency has in effect changed the 510(k) program without statutory authorization by: inappropriately considering clinical utility and benefit; interpreting "general versus specific intended use" so narrowly...

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