Heart valve guidance
This article was originally published in The Gray Sheet
Executive Summary
FDA begins preliminary discussions with International Standards Organization regarding revision of the 1994 draft guidance on replacement heart valves, the agency says. Division of Cardiovascular Devices staff also met with AdvaMed Heart Valve Working Group Feb. 7 to "open dialogue" related to the agency's plan for the new guidance, including "concerns related to shelf-life testing, particularly with regard to requirements to perform engineering, biocompatibility and animal tests on aged whole valves; and to test aged components in addition to aged whole valves," according to a letter from AdvaMed Associate VP Jeff Secunda to DCD Chief Bram Zuckerman...