January 15, 2025
FDA will phase out its general enforcement discretion for LDTs in stages. To assist with compliance, the toolkit includes a checklist to prepare for Stage 1 and a process overview flowchart that outlines the three requirements taking effect May 6, 2025.
In addition, AABB is hosting a webinar, Countdown to Compliance: Preparing for Stage 1 Phaseout - Implementation of the FDA’s Final Rule on Laboratory Developed Tests, from 2– 3:15 p.m. ET on Jan. 15 to provide information.
Members with questions may contact regulatory@aabb.org.