HEART VALVE ALLOGRAFTS NO LONGER REQUIRE PMAS, WILL BE MOVED TO CLASS II; FDA POLICY CHANGE FOLLOWS SETTLEMENT OF LITIGATION WITH TISSUE BANKS
This article was originally published in The Gray Sheet
Executive Summary
Heart valve allografts can be distributed without premarket approval or 510(k) clearance if a processor or distributor marketed the products prior to June 26, 1991, the agency says in a Oct. 14 Federal Register notice announcing that it ceased enforcing premarket approval requirements for heart valve allografts on the same day.