EU-style device regulatory system advocated by Progress & Freedom Foundation.
This article was originally published in The Gray Sheet
Executive Summary
EU-STYLE DEVICE REGULATION RECOMMENDED BY PROGRESS & FREEDOM FOUNDATION, a Washington, D.C.-based think tank with close ties to House Speaker Newt Gingrich (R-Ga.). In a "white paper" on "the future of medical innovation" released June 19, PFF joins the bandwagon of advocates of third-party reviews of medical devices; however, PFF takes the concept a step further by suggesting adoption of the European Union's four-class regulatory system and standards akin to the EU's "essential requirements."