The FDA’s Final Rule to Regulate Laboratory-Developed Testing Services (LDTs): What Laboratory Leaders Need to Know to Get Prepared

Despite ACLA-led lawsuit, Laboratories Should Still Prepare for Rule

On May 6, 2024, the FDA published its Final Rule to regulate laboratory-developed testing services (LDTs) under the Food, Drug & Cosmetic Act (FDCA). This Final Rule will impact laboratory leaders and their diagnostic organizations. While there are still many questions to be answered, here is a summary of what you need to know about the new rule to help you and your team prepare.

What is the FDA’s Final Rule? 

The Final Rule expands the definition of in vitro diagnostic (IVD) products to include those developed by laboratories and initiates a phased enforcement of these regulations. This means that LDTs will now be regulated similarly to medical devices.

The key takeaways from the final rule include:

• Broad Regulation of LDTs: The FDA’s regulation covers all LDTs with limited exceptions and targeted enforcement discretion for specific test categories.
• Enforcement Discretion: In the final rule, the FDA specified certain tests that will be subject to enforcement discretion, meaning they will not be subject to all regulatory requirements.
• Staged Phaseout: FDA will gradually eliminate its traditional enforcement discretion over a span of four years.

Staged Phaseout

The FDA will phase out enforcement discretion over five stages within four years:

Enforcement Discretion

Four categories of tests are not subject to any enforcement requirements: “1976-type” LDTs using manual techniques, HLA tests for transplantation, tests used within the DoD or VHA, and forensic tests and public health surveillance tests.

The FDA will exercise targeted enforcement discretion for specific categories of tests:

• Currently Marketed LDTs – Pre-market review and most quality system requirements are not enforced, provided they remain unmodified.
• Integrated Healthcare System LDTs – Pre-market review and most quality system requirements are not enforced for LDTs meeting an unmet need within a healthcare system. Note that if another laboratory receives FDA clearance and brings to market a comparable test, the “unmet need” exemption will no longer apply.
• New York State (NYS) Clinical Laboratory Evaluation Program (CLEP) – Approved LDTs: Pre-market review is not enforced for LDTs approved by NYS CLEP.
• Modifications to Cleared Tests – Pre-market review is not enforced for specific modifications made by CLIA-certified labs to 510(k) cleared or De Novo-authorized tests.

Click image to enlarge.

Recommendations for Keeping Currently Marketed LDTs (Pre-May 6, 2024) on the Market 

Currently marketed LDTs, including non-manual IHC staining, are subject to the following under the Final Rule…

• Stage 1: Compliance with post-market reporting requirements (e.g., MDR, adverse events, corrections, and removals) and quality system complaint file requirements.
• Stage 2: Compliance with FDA registration, listing, labeling, and investigational use requirements. Labeling requirements are extensive and must be completed retrospectively within two years.

Proactive Steps for Laboratories 

Although there is much up in the air about the Rule, the XiFin team recommends laboratories prepare for the new rule by:

• Understanding Stage 1 requirements, including establishing written procedures, hiring and training required personnel, and evaluating QMS software options.
• Evaluating pre-market pathways for new LDTs, including determining the regulatory path for tests, planning necessary testing, and gathering information for FDA submissions.

The Impact and Industry Response 

On May 29, 2024, the American Clinical Laboratory Association (ACLA) announced that it and its member company, HealthTrackRx, filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the Eastern District of Texas, challenging the Agency’s May 6, 2024, Final Rule, which inappropriately seeks to regulate professional laboratory testing services as medical devices under the Federal Food, Drug, and Cosmetics Act (FDCA).

The XiFin team recommends that laboratories continue their preparations for the new rule while this suit works its way through the court system.

According to Jondavid Klipp, the publisher of Laboratory Economics, the FDA’s Final Rule will affect at least 3,000 hospital labs and 2,500 independent labs currently performing LDTs.

In a recent webinar, “Decoding the FDA’s Final Rule on LDTs,” he also stated that new LDTs developed post-May 6, 2024, will likely face significant barriers due to high costs and regulatory requirements.

The FDA’s Final Rule signifies a transformative shift in regulating LDTs. Laboratory leaders must navigate this regulatory landscape by understanding the phased requirements, preparing for compliance, and evaluating the implications for their testing services. While challenges lie ahead, proactive planning and adaptation will be crucial for maintaining compliance and ensuring continued diagnostic excellence.

The FDA has made resources available to address some of the common questions laboratory leaders have regarding the Final Rule. We encourage you to review them.

FDA – In Vitro Diagnostics
FDA – Presentation Slides: FDA’s Final Rule Including a Phaseout Policy Regarding Laboratory Developed Tests