Advocacy Update: Court Strikes Down
FDA Overreach on In Vitro Diagnostics
On April 1, 2025, the U.S. District Court for the Eastern District of Texas determined that the Food and Drug Administration’s (FDA) 2024 final rule subjecting in vitro diagnostic products (IVDs) to unprecedented regulatory scrutiny is unlawful. Read our response here.
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.
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.
Legislation to Prevent the Overregulation of Laboratory Developed Tests Introduced
Reps. Brad Finstad (R-Minn.) and Dan Crenshaw (R-Texas) have introduced legislation to stop the overregulation of laboratory developed tests. H.R. 1463, the Freedom for Laboratory…