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