Issued in March, the FDA’s Final Rule on laboratory developed tests (LDTs) marks a departure from nearly 50 years of established regulatory standards. This means testing labs will soon face a dramatic shift in how they operate.
The Final Rule mandates new quality documentation records, registration procedures, and error reporting protocols that most testing labs aren’t yet equipped to deliver. Released with an aggressive four-year implementation timeline, the new standards threaten to disrupt your lab’s operations and delay critical testing services for patients.
It’s likely these new standards will undergo changes as its deadline approaches. Lawmakers have already warned the FDA that the scope and speed of these changes could upend lab testing and reduce patient access to vital information. However, you need to understand what the Final Rule means for your testing laboratory — and what you need to do now.
What Labs Need to Know About the FDA’s Final Rule on LDTs
The Final Rule hinges on a crucial redefinition: LDTs now fall under the federal classification of medical devices, alongside in vitro diagnostics (IVDs). While only 10 words were added to the regulation, this small change carries enormous implications.
The scope of the Final Rule is broad. It encompasses tests designed, manufactured, and used at single CLIA-certified locations, as well as tests offered by CLIA-certified labs. However, the FDA will maintain its current enforcement discretion in several areas, including:
- LDTs without automated preparation or interpretation (e.g., immunohistochemistry tests).
- Tests using staining antibodies and reagents for cytology, hematology, and bacterial infections.
- Forensic tests intended solely for law enforcement.
- LDTs developed within VA hospitals and the Department of Defense.
The following tests are also exempt from the changes in the FDA’s Final Rule:
- Direct-to-consumer tests.
- Tests for screening blood, human cell, or tissue donors.
- Emergency use tests.
- Tests manufactured or used outside clinical labs.
This comprehensive redefinition of LDTs introduces a host of new requirements. Labs must navigate a complex landscape of quality documentation, registration procedures, and error reporting protocols. Even with a staged rollout, the Final Rule will see most labs struggle to find the budget or administrative capacity to comply.
The FDA’s Four-Year Implementation Plan for LDTs
Issued on May 6, 2024, the Final Rule officially went into effect on July 5. However, the FDA instituted a four-year “phase out” period for your laboratory to adopt specific requirements.
Make no mistake — this is an aggressive timeline, given the scope of the changes. LDTs need to secure compliance in the following stages:
Stage 1: Reporting and Complaint Handling (May 6, 2025)
Beginning one year after the Final Rule’s publication, labs must comply with new medical device reporting (MDR) requirements. This includes corrections, removals reporting, and complaint handling for assays.
Stage 2: Registration and Labeling (2026)
Establishment registration, device labeling, and investigational use compliance kick in starting in year two.
Labeling also includes information related to unique device identifiers (UDIs) so lab workers can trace test components and reagents. With only a two-year timeframe for adoption, this requirement needs to be among your lab’s first priorities.
Stage 3: Quality System Regulation (2027)
The third year brings quality system regulation (QSR) compliance for medical device manufacturing. This stage introduces changes to LDT design work and documentation.
Like with Stage 2’s requirements, your lab should prioritize a plan to adapt to these new processes.
Stages 4 and 5: Premarket Review Requirements (Late 2027-2028)
The last two stages focus on premarket review requirements for certain assays. On November 6, 2027, high-risk LDTs will be subject to the Final Rule’s changes, followed by low- to moderate-risk tests on May 6, 2028.
Industry Response and Potential Challenges
These mandated changes have sparked significant pushback. The American Clinical Laboratory Association (ACLA) filed a lawsuit to vacate the Final Rule, which included support from executives at Labcorp, Quest Diagnostics, and Mayo Clinic Laboratories. This legal challenge underscores the industry’s concerns about the rule’s far-reaching implications and their potential to stifle diagnostic innovation.
Congress has also weighed in. The House Appropriations Committee requested the FDA suspend implementation efforts, citing potential disruptions to the U.S. laboratory testing infrastructure. Central to their concerns is the potential for reduced patient access to diagnostic information for conditions like heart disease, cancer, and Alzheimer’s.
Labs face a fork in the road. Should you ignore the rule in the hopes it will be amended or vacated? Or is it better to over-invest in compliance measures through hiring staff and overhauling processes? Both options carry their own risks. Regardless, you should understand where the Final Rule impacts your lab’s work to clear a path toward compliance.
4 Strategies for Testing Labs to Achieve FDA Final Rule Compliance
While the fate of the FDA’s Final Rule remains uncertain, your lab can’t afford to ignore its potential impact. Here’s how to position your lab for success:
1. Prioritize Based on the FDA’s Staged Phase Out
Align your efforts with the FDA’s implementation timeline as well as your lab’s greatest needs. First, plan next steps for medical device reporting and complaint handling, then address establishment registration and labeling.
2. Plan for Investments in Infrastructure and Personnel
To meet the new quality system requirements in the Final Rule, it will most likely demand additional resources. Consider steps to upgrade your laboratory information management system (LIMS) so your documentation complies with new standards. As the deadline approaches, you may also need to bring on additional staff.
3. Develop a Labeling and UDI Strategy
Unique device identifiers (UDIs) are relatively new territory for many labs. Your team should map all components and reagents used in your tests. Then, design a system to track and label these elements. This not only aids compliance but can also improve how your lab handles inventory management and traceability.
4. Create a Risk-Based Timeline
Prioritize high-risk LDTS in your compliance plan. Assess your test menu and create a timeline that addresses these tests first, followed by those that are moderate and low-risk.
When you take these steps, you’ll not only prepare for potential regulatory changes but also improve your lab’s efficiency. Stay informed of changes to the Final Rule while remaining flexible to planning adjustments in strategy as the situation develops.
Navigate a New Regulatory Landscape of Laboratory Testing
The FDA’s Final Rule on LDTs presents a seismic shift in the regulatory landscape. While ongoing challenges to the rule may alter its future, your lab can’t afford to take a wait-and-see approach. You have to be proactive to protect your lab’s continued operations.
You should conduct a thorough assessment of your lab to identify gaps in your quality systems, documentation procedures, and reporting capabilities. When possible, engage the FDA through official channels to provide feedback on practical implementation challenges. Your input could shape the final outcome.
If you take control of your compliance journey now, you’ll be better positioned to navigate the new regulatory landscape, regardless of how the Final Rule evolves.
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