The U.S. Food and Drug Administration (FDA) recently proposed regulations for Laboratory Developed Tests (LDTs), sparking intense debate among key healthcare and diagnostic testing stakeholders. As experts in guiding In Vitro Diagnostics (IVDs) and Medical Devices through the complex requirements for FDA clearance/approval, the Regulatory Affairs team at MDC Associates offers a closer look at the background, motivations, and potential implications of these proposed regulations.

 

Background and Significance

The FDA has long maintained that it has the authority to regulate LDTs. While the FDA has exercised enforcement discretion policy towards LDTs, they have not generally enforced premarket review or other FDA regulatory requirements for LDTs, except for certain categories, such as direct-to-consumer tests and some pharmacogenomic tests.

Historically, there have been ongoing discussions and advocacy efforts surrounding the regulation of LDTs with stakeholders, the FDA, and Congress. The critical debate revolves around whether LDTs qualify as medical devices and whether the FDA has the legal authority to regulate them. Some life sciences industry segments have challenged the agency’s authority to regulate LDTs. They argue that LDTs already receive adequate oversight through the Clinical Laboratory Improvement Amendments (CLIA) and the expertise of laboratorians.

Clinical laboratory testing plays a crucial role in healthcare, informing an estimated 70 percent of healthcare decisions. These tests, including those developed during health emergencies like COVID-19, are pivotal in the medical landscape. For instance, some LDTs are the only clinical tests available to detect certain substances. Two examples already widely mentioned are fentanyl and xylazine.

 

The Recent Shift

In recent years, Congress has worked with key stakeholders on legislative proposals for regulating diagnostics, including LDTs. The legislation called the Verifying Accurate Leading-edge IVCT Development (VALID) Act which would grant FDA the authority to regulate LDTs, failed to pass at the end of 2022. This effort was a significant development, and in the spring of 2023, the FDA announced its intention to initiate rulemaking for LDTs. On September 29, 2023, the FDA issued a highly anticipated proposed rule to regulate LDTs as medical devices by updating the regulatory definition of in vitro diagnostic products stating that IVDs are considered a device “including when the manufacturer of these products is a laboratory.”

 

Understanding the Proposed Rule

The FDA’s proposed rule introduces changes to the definition of “in vitro diagnostic products” within FDA regulations, explicitly encompassing IVDs manufactured by laboratories. The proposal outlines a phased approach to reduce the FDA’s general enforcement discretion for LDTs, concentrating on various categories of requirements over several years.

However, specific test categories, including “1976-type LDTs,” Human Leukocyte Antigen tests, forensic tests, and tests for public health surveillance, will continue to be under enforcement discretion, subject to specific conditions.

FDA’s Rationale

The FDA underscores the “high variability” of LDTs, encompassing high-risk and low-risk tests for rare diseases. Their recent experiences with COVID-19 tests, especially regarding validation, have further fueled the need for oversight. Scientific literature, medical reports, patient complaints, and experience from the COVID-19 pandemic have led the FDA to recognize the critical importance of ensuring test validity and accuracy.

Phased Implementation

The FDA introduces a phased approach to the enforcement discretion policy. This approach, which will be further detailed in the preamble to the final rule, aims to gather information on potential public health and safety risks associated with LDTs promptly.

 

Stakeholders’ Concerns

Several key stakeholders, including the Academy of Clinical Laboratory Physicians and Scientists, the American Red Cross, and the American Hospital Association, requested an extension of the comment period. Their concerns revolve around the proposed rule’s potential impact on patient access to tests, clinical practice, and innovation. The American College of Medical Genetics and Genomics has asked for a 120-day extension, emphasizing the complexity of the proposed rule.

One significant stakeholder, the American Clinical Laboratory Association (ACLA), argues that the FDA lacks the legal authority to regulate LDTs, claiming that this oversight should fall under the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA). ACLA supports legislative reform to establish a new pathway for in-vitro diagnostics instead of FDA regulation and urges the FDA to resumes its work toward legislative solution.

There is concern that the FDA is already under-resourced and unprepared to complete all the new work the agency has proposed to undertake. The FDA may seriously risk falling behind on its current public health priorities.

The FDA’s decision not to extend the comment period for the proposed LDT rule has taken many by surprise, as stakeholders had expected an extension to facilitate further discussions and give Congress more time to address diagnostic reform legislation. With thousands of comments submitted, including requests from key stakeholders for an extended deadline, the debate over the regulation of LDTs is intensifying.

 

Looking Ahead

The FDA’s proposed rule for Laboratory Developed Tests has spurred numerous questions and uncertainties. It highlights the need for regulatory oversight to ensure patient safety in a rapidly evolving diagnostic testing landscape. The ongoing debate involves complex legal, economic, and public health considerations. Collaborative efforts among stakeholders, congressional action, and comprehensive public input will shape the future of diagnostic testing regulation in the United States.

With the comment period now closed, the Unified Agenda was updated to indicate the FDA may publish a final rule as early as April 2024.

 

Our Perspective

At MDC Associates, we understand the intricacies of navigating the FDA’s evolving regulatory landscape. Our expertise lies in assisting IVDs and Medical Devices through the rigorous approval process to obtain marketing authorization.

For Industry Stakeholders

As the FDA’s proposed rule for Laboratory Developed Tests continues to generate debate and discussion, we recommend that industry stakeholders, with or without LDTs, consider short and long-term impacts and seek expert advice specific to their unique business. We can help you form early strategies considering alternative regulatory outcomes, so your regulatory initiatives remain agile and moving forward.

For Clinical Laboratories

We recommend clinical laboratories consider implementing FDA-compliant quality systems and planning for regulatory oversight. The four-year phased approach proposed by the FDA allows laboratories time to thoughtfully plan and take action, especially regarding offering their tests under stricter agency regulation.

Labs currently offering LDTs may also benefit from assessing the broader impacts on healthcare professionals, patients, and other customers who rely on their tests. Thoughtful planning and collaboration with stakeholders can help ensure continuity of care for patients.

 

Stay Informed

As this process unfolds, MDC Associates will continue to monitor developments and provide guidance on strategic planning. If you have questions or require assistance navigating this evolving issue, please get in touch with our Regulatory Affairs team.