ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA publishes its long-awaited and, in many quarters, hated lab-developed test rule; the US agency seeks feedback on advisory committees; CMS opens CardioMEMS coverage analysis, China summarizes typical violations; and digital and data news from Europe.
Top Picks
FDA’s LDT rule and Dx guides:
LDT countdown begins. Laboratory-developed tests (LDTs)—made and performed by a lab rather than sold as packaged kits—are now on the clock to conform to FDA device regulations. The agency published its closely watched and controversial LDT rule April 29 to make it plain that the test services are, in fact, medical devices and to set out a four-year timeline for them to transition into FDA’s risk-based regulatory scheme. For more details, see “Lab-Developed Test Countdown Begins: 4 Medtech Takeaways.”
