On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of diagnostic testing: the new rule governing Laboratory-Developed Tests (LDTs).  Unlike commercially available tests that are subject to premarket approval by the FDA, LDTs were originally intended to be restricted to diagnostic tests that are designed, manufactured, and used within a single laboratory, and were previously largely unregulated by FDA under a policy of enforcement discretion. Though these tests were still subject to oversight from other agencies such as the Centers for Medicare and Medicaid Services (CMS), the additional requirements raised by the new FDA rule will place a significant additional regulatory burden on clinical laboratories.

The primary objectives of the new FDA rule are to ensure that LDTs meet high standards of accuracy, reliability, and clinical validity, and to provide clearer oversight mechanisms. Key aspects include:

1. Premarket Review Requirements: Under the new rule, many LDTs will now require FDA premarket review in order to assess safety and effectiveness; this update will bring LDTs in line with the regulatory scrutiny applied to other diagnostic tests.
2. Risk-Based Classification: FDA will classify LDTs based on their risk level; higher-risk tests, particularly those used for serious or life-threatening conditions, will face more stringent requirements, while lower-risk tests will undergo a less rigorous process, though they will still be subject to some level of FDA oversight.
3. Submission of Evidence: Laboratories will need to submit evidence demonstrating the validity of their tests, including clinical data proving that the test performs as intended and provides accurate results.
4. Postmarket Surveillance: The new rule includes provisions for ongoing monitoring of LDTs once marketed to ensure that any performance or safety trends are promptly addressed.

The introduction of the new LDT rule is a response to growing concerns about the reliability and accuracy of some laboratory-developed tests, especially given the increasing complexity of diagnostic testing in modern medicine and FDA’s desire to minimize the risks to patient safety associated with potentially inaccurate or unreliable tests involved with either false positive or false negative results. Test quality should also improve, as premarket review, including compliance with the design control requirements described in both 21 CFR Part 820 and ISO 13485, will drive laboratories to adhere to higher quality standards and adhere to rigorous performance benchmarks.

The implications of this new rule for laboratories and other stakeholders in the healthcare industry are widespread. Laboratories will face both increased costs related to regulatory compliance (compliance with new requirements and compilation and preparation of regulatory filings) and increased time to market as a result of these additional compliance needs, potentially impacting innovation. Additionally, smaller laboratories might find it more challenging to meet the new requirements compared to larger institutions with more resources, which could potentially affect the availability of certain niche tests.

As the FDA implements this new rule, its impact on the diagnostic testing landscape will become clearer. While there may be challenges and adjustments ahead, the overarching goal is to enhance the reliability and effectiveness of LDTs, ultimately benefiting patient care.

For laboratories, staying informed and prepared for these changes will be crucial. Embracing the new regulatory environment while continuing to drive innovation will ensure that the evolution of diagnostic testing aligns with the best interests of public health.

Interested in learning more about how the FDA’s final rule on LDTs may impact your company? Reach out to us today to start a conversation!