FDA regulation of blood center lab tests may risk critical, life-saving procedures.
Laboratory developed tests in blood centers are critical for urgent, life-saving situations. They provide rapid information for time-sensitive medical decisions and ensure safe transfusions. Blood centers already operate under a comprehensive regulatory framework, including federal and state licensure, CLIA certification, FDA compliance, and accreditation. This multi-layered approach ensures rigorous oversight and patient safety.
The Problem
In May 2024, the FDA issued a far-reaching final rule that subjects in vitro diagnostic products (IVDs) to unprecedented regulatory scrutiny.
Right now, blood centers are preparing to implement this mandate that will significantly impact laboratory developed tests (LDTs), potentially jeopardizing critical, life-saving procedures.
The rule threatens to create a perfect storm of delayed patient care, increased costs, stifled innovation, and resource diversion—all of which could compromise the efficiency and effectiveness of blood center operations.
Congress has expressed reservations about the FDA's new regulatory framework, questioning whether it falls within the agency's authority. This sentiment aligns with the broader healthcare community's concerns about the potential impact on patient care.
Take Action
America's Blood Centers supports exempting LDTs used by blood centers from new diagnostics regulations. These tests are already subject to rigorous oversight and are crucial for maintaining a safe and reliable blood supply. To ensure uninterrupted, life-saving care for patients across America, we urge Congress to encourage the FDA to revoke the 2024 Lab Developed Test final rule and exempt blood center LDTs from any new reforms of LDT regulation.
Add your voice to these efforts by sending customizable, prewritten messages to your Members of Congress - it takes only minutes but could have a lasting impact.
Resources
Food and Drug Administration (FDA)
The FDA's website provides information about Laboratory Developed Tests (LDTs) and addresses frequently asked questions related to them.
Food and Drug Administration (FDA)
This page announces actions taken by the FDA to ensure the safety and effectiveness of Laboratory Developed Tests (LDTs). The FDA has implemented a final rule to provide oversight of IVDs (in vitro diagnostic products) manufactured by laboratories and issued policies to phase out enforcement discretion for LDTs over four years.
FDA Sued Over Laboratory Developed Tests Final Rule
This page from the National Law Review provides legal analysis and updates on the Food and Drug Administration (FDA) being sued over its Final Rule on Laboratory Developed Tests (LDTs). The analysis includes details of the lawsuits, arguments presented by plaintiffs, responses from the FDA, and upcoming steps in the legal process.
ABC Supports the Freedom for Laboratory Innovation and Testing Act
America’s Blood Centers strongly supports the Freedom for Laboratory Innovation and Testing Act. This legislation, introduced by Representatives Finstad and Crenshaw, aims to prevent federal…