Article

FDA's Proposed Rule for Laboratory Developed Tests (LDTs):

Ensuring Safety and Effectiveness

 

On September 29, 2023, the FDA's announced introduction of a proposed rule to regulate Laboratory Developed Tests (LDTs) as IVDs that fall under the Food and Drug Cosmetic Act, marking a significant shift for the FDA to phase out the era of enforcement discretion for LDTs. The FDA intends to have great oversight of LDTs, wherein LDTs manufactured by laboratories would fall under similar enforcement approaches as IVDs. Increases in the prevalence (use), technological complexity, and reported safety and performance issues with LDTs were cited as factors in the decision for FDA rulemaking. The benefits of additional oversight of LDTs, enhance patient care, diagnostic accuracy, and the reliability of LDTs, ensuring that they continue to play a vital role in healthcare and scientific research.

 

Background on LDTs

LDTs, or Laboratory Developed Tests, are in vitro diagnostic products used for clinical purposes, primarily within a single laboratory. They play a critical role in healthcare by providing diagnostic information.  

 

FDA's Intent to Regulate LDTs

The FDA's proposed rule aims to explicitly classify IVDs, including those developed by laboratories, as IVDs under the Federal Food, Drug, and Cosmetic Act. This change signifies a desire for increased oversight of LDTs, moving away from enforcement discretion.

 

Increased Oversight

One of the most noticeable consequences of this proposed rule is the increased oversight that laboratories offering LDTs will face. While the regulation details are yet to be determined, laboratories will likely be required to meet specific test performance, quality, and safety standards. 

 

Compliance with FDA Regulations

Laboratories must adapt to the new regulatory requirements and comply with the FDA's rules and guidelines for medical devices. It will likely involve submitting pre-market notifications, obtaining clearances or approvals, and possibly undergoing inspections to ensure compliance with the regulations.

 

Impact on RUO Products

Manufacturers of RUO products may also be affected by the FDA's proposed rule for LDTs. Laboratories often use RUO products to develop and validate LDTs. With increased oversight and regulation, the requirements for RUO products may change, potentially impacting their availability and use in laboratory settings.

 

Third-Party Review and the Future of LDT Regulation

In its announcement, the FDA mentions explicitly an increase in the use of Third-Party Review, a critical element in evaluating medical devices and ensuring their safety and effectiveness. This shift towards Third Party Review may streamline the regulatory process and provide an additional layer of expertise in assessing LDTs.

 

At Landrich Group, we are passionate about delivering tailored Clinical, Quality, and Regulatory consulting services to Medical Device, IVD, and Pharmaceutical companies. Our unwavering commitment to staying at the forefront of evolving medical diagnostics regulations ensures that we are a trusted partner in adaptation.

With the FDA's changing stance on LDTs, we are dedicated to guiding our clients through compliance with upcoming regulations. We provide the necessary support, ensuring they navigate this shifting regulatory landscape with confidence.

As the FDA's proposed rule for LDTs unfolds, Landrich Group remains devoted to supporting our clients and fostering responsible innovation, all while maintaining our commitment to safety and effectiveness in diagnostics.

 

For more information about our services, please visit our website at www.landrichgroup.com, or contact us at admin@landrichgroup.com for a complimentary consultation.