FDA Convenes Industry, Physicians To Create International Transcatheter Valve Registry Consortium
This article was originally published in The Gray Sheet
Executive Summary
The agency held a stakeholder meeting to discuss the creation of an international consortium of transcatheter valve registries to serve as the model for future cardiovascular device registry collaborations.
You may also be interested in...
AdvaMed Emphasizes Threshold Questions, Data Governance In Registry Principles
The trade group released revised data registry principles aimed at ensuring adequate data governance and containing “threshold questions” one should consider before implementing a registry as opposed to another form of information gathering.
TAVR Registry Data Triggers Expansion Of FDA-Approved Indication
FDA has changed the indication for transcatheter aortic valves to include any access approach for inoperable patients. The new indication, based largely on registry data, is significant due to the “message that FDA is sending in that they are looking at ways of post-market surveillance,” said surgeon Michael Mack.
CDRH Details Path Forward For National Post-Market Surveillance System
The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.