ARTICLE SUMMARY:
In this week’s Pathways Picks: Transcatheter tricuspid valve devices are among the first to pilot CMS’ Transitional Coverage for Emerging Technologies pathway; FDA plans new policies for ethylene oxide sterilization changes; the International Medical Device Regulators Forum accepts new members and approves new guides; the EU Parliament meets; a new IVDR guidance document is released; the Netherlands scrutinizes postmarket surveillance efforts; and more from Brazil, India, and the US.
Top Picks
TCET and EtO efforts:
Tricuspid valves help launch TCET. CMS’ recently launched Transitional Coverage for Emerging Technologies (TCET) pathway appears to be getting its first tryouts with two new transcatheter tricuspid valve devices. The agency opened a national coverage analysis (NCA) October 3 for the transcatheter edge-to-edge repair for tricuspid valve regurgitation (T-TEER) procedure performed with Abbott Laboratories’ recently FDA-approved TriClip device, identifying the NCA as a pilot for TCET. (For more: “Tricuspid Valve Devices Help Launch TCET,” Market Pathways, October 9, 2024.)
EtO policies advance. FDA is planning to issue a guidance document outlining a “transitional enforcement policy” for making ethylene oxide sterilization facility changes for Class III devices. The guidance was submitted by the agency to the White House Office of Information and Regulatory Affairs last week, signaling likely release in the next few months. The agency is already running multiple programs to facilitate manufacturers’ move away from EtO following the Environmental Protection Agency’s recent rule restricting emissions of the gas used to sterilize many devices. In addition, this week, FDA is hosting its latest online town hall on device sterilization to spotlight the prospect of employing “predetermined change control plans” to streamline sterilization-related modifications.
