LBITF, FDA "Concept and Principles" Draft Attests Collaborative Effort
This article was originally published in The Gray Sheet
Executive Summary
Reviewers of 510(k) premarket submissions should limit their analyses to claims "that present a major impact on the intended use of the device," according to principles set forth in a least burdensome industry task force (LBITF) and FDA draft document released for comment on FDA's website March 20.