REGULATORY UPDATE: AABB Releases Laboratory-Developed Tests - Stage 1 Toolkit

January 15, 2025

AABB is pleased to introduce a new toolkit, Laboratory-Developed Tests - Final Rule - Stage 1 Phaseout, to support members in planning for compliance with upcoming medical device reporting (MDR) requirements, corrections and removals reporting requirements, and quality system requirements. These new regulations take effect May 6, 2025. 

The Food and Drug Administration’s May 6, 2024, final rule modifies the definition of in vitro diagnostic products (IVDs) to explicitly include laboratory-developed tests (LDTs). Since IVDs are defined as devices, all LDTs, including those manufactured by laboratories, will now fall under the regulatory framework governing devices. 

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