FDA Will Not Broadly Release Report Criticizing EU Oversight
This article was originally published in The Gray Sheet
Executive Summary
The agency decided not to widely disseminate a report examining 12 high-risk devices that were approved in Europe, but were later found to be dangerous or ineffective.
You may also be interested in...
FDA: Factoring In Reimbursement, U.S. Bests Europe In Access To Innovative Devices
FDA officials refute claims, frequently made by industry, that because FDA’s PMA review process is much slower than the CE mark regulatory process in Europe, Americans suffer delayed access to innovative and life-saving technology.
International News In Brief
Medical device news from around the world.
Shuren: "We Don't Use Our People As Guinea Pigs In The U.S."
CDRH Director Jeffrey Shuren specifically responded to the PwC report during the Jan. 19 press conference on the 510(k) reform plans.