USER FEE BILL WILL PROVIDE "IMMEDIATE" 510(K) EXEMPTION
This article was originally published in The Gray Sheet
Executive Summary
USER FEE BILL WILL PROVIDE "IMMEDIATE" 510(K) EXEMPTION for Class I devices in the Tier I administrative review category and an exemption for Class II devices in Tier I sometime in the future, the Health Industry Manufacturers has been told by a congressional aide involved in drafting medical device user fee legislation.