The FDA has issued its long-awaited decision regarding the regulation of Lab Developed Testing (LDT) on May 6, 2024. In this ruling, the FDA categorizes LDTs as 'medical devices' if they are created by laboratories rather from medical device companies, known as In-vitro diagnostics devices (IVDs). Despite resistance from the laboratory community, the FDA maintains its classification of LDTs as medical devices.

This ruling holds significant implications for laboratory organizations, especially those currently offering testing developed in-house for patient care. The American Society for Clinical Laboratory Science (ASCLS) anticipates that high-complexity laboratories across the country will be significantly affected by this final ruling. Many worry that innovation could be stifled with more regulation governing development of critical tests such as new cancer markers, Alzheimer’s, and rare disease assays. Large lab organizations, such as ARUP, have serious concerns regarding the ruling for LDT governance citing negative impact on patient care and incentives for new test development.

The FDA's decision includes provisions to grandfather in six categories of existing LDTs already on the market as of May 6, 2024. Additionally, exemptions are provided for LDTs approved by other state and governmental agencies. Detailed information on exempt categories is available for review here.

Implementation of the FDA ruling will take place in five stages spanning a four-year period. Laboratories utilizing current LDT tests must adhere to a series of regulatory requirements, including compliance with Medical Device Reporting (MDR) and maintaining quality system complaint files through 2026. Subsequently, beginning May 6, 2027, compliance with premarket review requirements for high-risk tests is expected, followed by medium and low-risk tests in 2028. Consequently, LDTs existing on the market as of May 6, 2024, will be required to undergo the full FDA application and clearance process, while any new LDTs developed after this date will also need to undergo a complete clearance process, including premarket review.

Many industry partner organizations advocate for a risk-based approach, which was introduced to both chambers of Congress in May 2020, as the VALID Act (Verifying Accurate Leading-edge IVCT Development). This proposed framework seeks to distinguish LDTs from traditional medical devices. The VALID Act was re-introduced in Congress in 2021 and 2022 and is currently pending in Congress with insufficient bipartisan support.

In response to the FDA ruling, the ASCLS organization is planning training sessions and educational forums to assist laboratories in navigating and implementing these new regulations.

More resources are listed below:

FDA Final Rule

CDC’s Laboratory Outreach Communication System

Agency(Q - Your New Regulatory Intelligence Experts