• Institute of Medicine Recommends a Complete Overhaul of the 510(k) Process
  • August 12, 2011 | Author: Nicole L. Grimm
  • Law Firm: Skadden, Arps, Slate, Meagher & Flom LLP - Washington Office
  • On July 29, 2011, the Institute of Medicine (IOM) released the long-awaited report of its Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process (IOM Committee). The IOM Committee was tasked by the Food and Drug Administration with assessing the current 510(k) process and recommending changes to the program. To the surprise of many, the IOM Committee’s Report recommends a complete overhaul of the 510(k) process.