The Future of Laboratory Developed Tests Under FDA Scrutiny
Contributing Expert at Medrio: Tina Caruana , Director of eClinical Solutions
In May 2024, the FDA released its Laboratory Developed Tests (LDTs) Final Rule.??
Until recently, LDTs were exempt from FDA oversight. According to the FDA, this new policy will help ensure the safety and efficacy of these tests while assuring patient access and reliance. Meanwhile, many industry leaders oppose the new policy.?
In July 2024, the House Appropriations Committee told the FDA to suspend the final rule's implementation and partner with Congress to revise it.
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Main Takeaways from the FDA LDT Regulation
The FDA estimates that 80,000 LDTs are currently on the market, with nearly 8,000 new LDTs introduced each year. Until now, the FDA has taken an enforcement discretion approach to LDTs. They are phasing out this hands-off approach.?
In the final rule, the FDA makes it clear that IVDs are devices under the Federal Food, Drug and Cosmetic Act, including when the IVD manufacturer is a laboratory.?
IVDs manufactured by laboratories will now fall under the same enforcement approach as other IVDs.
The final rule applies to LDTs:
The FDA states that “the risks associated with most modern LDTs are much greater than the risks that were associated with LDTs used decades ago”.?
The agency expressed concern that some LDTs may not provide accurate test results. It also casts doubt on whether LDTs perform as well as FDA-authorized tests and others complying with FDA requirements.
The FDA cites data from the Centers for Disease Control and Prevention (CDC), stating that “70% of today’s medical decisions depend on laboratory test results. Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health”.
There are a few exceptions to the final rule , including:
What does this mean for LDT manufacturers?
Under the FDA’s new policy, LDTs are subject to a more rigorous premarket review process. Manufacturers must register new LDTs with the FDA and report adverse events to the agency.
LDTs will fall under device requirements, including:
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Phaseout Policy Enforcement
Under the final rule, the FDA proposes phasing out the former approach to LDTs over four years to address patient access and reliance.
Stage 1: Beginning on May 6, 2025, the FDA expects compliance with medical device reporting (MDR) requirements, correction and removal reporting requirements, and quality system (QS) requirements regarding complaint files.
Stage 2: Beginning on May 6, 2026, the FDA expects compliance with requirements not covered during other stages of the phaseout policy, such as registration and listing requirements, labeling requirements, and investigational use requirements.
Stage 3: Beginning on May 6, 2027, the FDA expects compliance with QS requirements.
Stage 4: Beginning on November 6, 2027, the FDA expects compliance with premarket review requirements for high-risk IVDs offered as LDTs. If the FDA has already received a premarket submission by the beginning of this stage, then it will continue to exercise enforcement discretion during its review.
Stage 5: Beginning on May 6, 2028, the FDA expects compliance with premarket review requirements for moderate-risk and low-risk IVDs offered as LDTs that require premarket submissions. If the FDA has already received a premarket submission by the beginning of this stage, it will continue to exercise enforcement discretion during its review.
Following this phaseout, the FDA expects LDT makers to meet all requirements. An exception will be made if laboratories can leverage certain requirements under the Clinical Laboratory Improvement Amendments (CLIA).
Industry Reaction to the Final Rule
Overall, the final rule has not been well-received by the industry. Some experts have raised concerns that the new regulations are problematic.?
Industry concerns include:?
In May 2024, the American Clinical Laboratory Association (ACLA) sued the FDA in an effort to stop the FDA’s new LDT rule.?
The ACLA argues that LDTs are services carried out by laboratory professionals. They argue that the FDA does not have the authority to enforce stricter standards on LDTs, nor regulate them as medical devices, and accuses the agency of regulatory overreach. The ACLA insists that LDTs are federally regulated by CMS under CLIA.?
In July 2024, the House Appropriations Committee expressed concern about implementing the final rule, stating that it has "the risk of greatly altering the United States' laboratory testing infrastructure." The final rule's implementation has been halted until the FDA partners with Congress to revise it.?
The Future of LDT Testing
Although the House Appropriations Committee has temporarily halted the final rule’s implementation, labs making LDTs must now clearly understand what these requirements may entail.?
The FDA promises to hold educational webinars, publish guidance documents, provide templates, and participate in conferences to help labs navigate the transition. Any IVD manufacturer can also use the FDA's question submission process for answers to specific questions.
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