News & Insights
FDA LDT Resources
Laboratory Developed Tests | FDA contains background information, phaseout policies, FAQs and resources including webinars related to the final ruling.
FDA LDT Update 7-1-2024
Supreme Court 'Chevron' Ruling and Potential Impacts to the New FDA LDT Ruling
On Friday, June 28th, 2024, the Supreme Court, in a 6-3 vote, overruled the 1984 decision in Chevron v. Natural Resources Defense Council. The “Chevron” ruling had required federal courts to defer to the reasonable interpretations of statutes by the agencies responsible for their enforcement. However, the new ruling states, “The Administrative Procedure Act requires courts to exercise their independent judgment in deciding whether an agency has acted within its statutory authority, and courts may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
This decision could have significant implications for various regulatory agencies, including the Food and Drug Administration (FDA). The critical question in the American Clinical Laboratory Association (ACLA) lawsuit against the FDA revolves around whether the FDA has the authority to regulate Laboratory Developed Tests (LDTs). The Supreme Court’s overruling of the Chevron decision may make it more challenging for the FDA to defend its regulatory actions, as courts will no longer automatically defer to the agency’s interpretation of its statutory authority.
As more information and opinions on the impact of this ruling are released, we will continue to provide updates.
FDA LDT Update 6-20-2024
Rep. Finstad and Rep. Crenshaw Introduce Resolution Against FDA Rule Restricting Access to Laboratory Developed Tests
As the laboratory community continues to voice concerns regarding the LDT ruling, we find more lawsuits and resolutions being filed to challenge its implementation.
- Impose regulatory burdens that hinder the development and deployment of new and improved lab-developed tests;
- Increase regulatory requirements that will lead to delays in patients’ access to critical diagnostic tests;
- Potentially hinder collaborative efforts in clinical care that rely on the flexibility provided by LDTs; and,
- Negatively impact small and medium-sized laboratories, which will face economic challenges with complying with the rule as written.
You can read more about the press release here.
FDA LDT Update 6-11-2024
American Clinical Laboratory Association (ACLA) Takes Legal Action Against FDA's Regulation of Laboratory-Developed Tests
ACLA, joined by HealthTrackRx, challenges FDA’s mandate on laboratory-developed test oversight with lawsuit.
Read more here.
FDA LDT Update 6-6-2024
Dr. Paul, Rep. Finstad Introduce Resolution to Repeal Harmful FDA Rule Limiting Access to Laboratory Developed Tests
On May 17, 2024, Senator Rand Paul introduced a resolution under the Congressional Review Act to repeal the FDA’s finalized rule on LDTs. Read more about the resolution here:
FDA LDT Update 5-10-2024
Dear Valued Clients,
The U.S. Food and Drug Administration (FDA) has issued a final ruling on the oversight of Laboratory Developed Tests (LDTs), which was published in the Federal Register on May 6th, 2024. We have been waiting to send out a notification as we needed more information as to how this might impact the LCMS confirmation LDTs specifically. While information and details are sparse, we do have some idea how this will impact existing LCMS confirmation methods/LDTs as well as new LDTs.
Key Highlights of the FDA Ruling:
- Amendment to Definitions: The FDA has modified 21 C.F.R. 809.3(a) to classify LDTs as in vitro diagnostics (IVDs) even when manufactured by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) that perform high complexity testing.
- Effective Date: The new regulation is set to be enforced starting May 6, 2024.
- Regulatory Oversight: This change places LDTs squarely under the jurisdiction of the FDA, aiming to ensure patient safety and test accuracy.
- Implementation: 5 stages over 4 years
- Stage 1 – May 6th, 2025
- Corrections and Removals (21 C.F.R Part 806)
- Medical Device Reporting (21 C.F.R Part 803)
- Complaint Handling (21 C.F.R. 820.198)
- Stage 2 – May 6th, 2026
- Register facility with FDA and list each LDT (21 C.F.R. Part 807)
- Compliance with Labeling requirements (21 C.F.R. Part 801 and 809)
- Compliance with applicable investigation device requirements (21 C.F.R. Part 812)
- Stage 3 – May 6th, 2027
- Compliance with Quality System (QS) or new (QMSR) (21 C.F.R. part 820)
- Stage 4 – November 6th, 2027
- PMA submission for high risk (Class III) LDTs
- Our best guess is that LCMS confirmation will not fall under this category.
- Stage 5 – May 6th, 2028
- Low (Class 1) and Moderate risk (Class II) requirement for 510(k) or De Novo submissions
- Stage 1 – May 6th, 2025
At Quasar, we are diligently monitoring these changes and their implications to the toxicology lab arena where we will continuously post updates and relevant information to this News & Insights page to help you stay informed.
To be frank, there are many more questions than answers at this stage and we are diligently monitoring the situation and will be providing updates, specifically on the toxicology LCMS confirmation LDTs.
Beyond the uncertainty of the impact of the current ruling as it stands, there is also uncertainty on the future of the ruling; specifically, the potential impacts of lawsuits, congress acting on the VALID act, or the impact of the November elections. As we move through the next few months, we will be updating the new FDA LDT section of our website as more information comes to light. We will also try to gather information on how we feel this will specifically impact the toxicology LCMS market.
Please note: There are areas where the FDA is exercising enforcement discretion. Specifically, these impact existing LDTs that were live before May 6th, 2024, and LDTs approved by the NYS CLEP program. There are other exceptions, but these are the major ones for toxicology.
While there is uncertainty in the future and the impact of the FDA LDT Ruling, we are moving forward with the planning on how to comply with stages 1, 2 and 3 as well as strategies for the existing LDTs and those approved by NYS CLEP program.
For any concerns or questions regarding how these changes might affect your laboratory, please do not hesitate to contact us at Quasar. We value your partnership and trust, and we are committed to navigating these regulatory changes together.
Thank you for your continued support.
Warm regards,
The Quasar Team