Throughout 2024, Applied Policy closely tracked and reported on the evolving oversight of laboratory-developed tests (LDTs), drawing on insights shared by stakeholders during our October 2023 webinar on the subject. In 2025, the regulatory landscape for LDTs may continue to shift. While the Biden administration sought to tighten FDA oversight, the incoming Trump administration may pursue a policy reversal.
Biden Administration Actions
In April 2024, the Food and Drug Administration (FDA) finalized a rule redefining LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This marked the end of decades-long enforcement discretion, with the FDA implementing a phased approach requiring premarket review and adherence to stringent quality systems. Supporters argued that the changes were necessary to ensure the safety and effectiveness of diagnostic tests, given their increasing complexity and critical role in healthcare decisions.
Key stakeholders, including the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP), argued that the final rule would stifle innovation, impose significant compliance burdens, and disrupt laboratories’ ability to address urgent public health needs.
By contrast, the Advanced Medical Technology Association (AdvaMed) described the FDA rule as a step towards ensuring LDTs “meet FDA’s rigorous standards for safety and effectiveness.” The group continues to advocate for passage of the Verifying Leading-edge IVCT Development (VALID) Act. (Read Applied Policy’s story on the VALID Act here.)
Legal and Advocacy Pushback
In May, ACLA filed a lawsuit in the Eastern District of Texas challenging the FDA’s final rule. The organization argues that the FDA exceeded its statutory authority, asserting that LDTs fall outside the scope of the FDCA’s medical device provisions. The suit seeks to vacate the rule entirely, raising questions about the FDA’s future role in regulating laboratory diagnostics. The Association for Molecular Pathology (AMP) has challenged the rule in a separate suit filed in District Court for the Southern District of Texas.
The College of American Pathologists (CAP) and the American Society for Clinical Pathology (ASCP) have appealed directly to Linda McMahon and Howard Lutnick, co-chairs of the Trump transition team, urging the incoming administration to rescind the rule. CAP’s letter emphasized the rule’s potential to disrupt patient care and limit innovation, while the ASCP cautioned that regulatory overreach could compromise laboratory operations. AMP has advocated for updates to the Clinical Laboratory Improvement Amendments (CLIA) and a return to the exercise of enforcement discretion.
The Trump Administration’s Role
The Trump administration’s response to these appeals could mean a new course for LDT regulation. Industry stakeholders anticipate a shift toward deregulation, consistent with the administration’s broader efforts to reduce federal oversight across healthcare sectors.
Broader Implications
The regulatory future of LDTs is more than an industry concern; it is a critical issue for patients, providers, and public health. LDTs can be vital in diagnosing diseases, from rare genetic conditions to widespread public health threats. Striking the right balance between innovation and oversight remains a delicate challenge, as recent public health emergencies, including COVID-19, have underscored the need for reliable diagnostics and rapid test development.
The Trump administration’s approach to LDT regulation could have far-reaching consequences, shaping the trajectory of diagnostic innovation and healthcare delivery for years to come.
Looking Ahead
The coming months will be pivotal in determining whether the FDA’s final rule stands, is modified, or is rescinded entirely. With ongoing legal challenges and active stakeholder engagement, the debate over LDT regulation is far from over. For laboratories, policymakers, and healthcare providers, the stakes remain high. Applied Policy will continue to monitor and report on developments.