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Advocacy - Lab Advocate

ADLM calls for Congressional Action to address FDAs Final Rule on LDTs

ADLM has expressed strong concerns over the final rule issued by the U.S. Food and Drug Administration (FDA) that unilaterally extends the agency’s oversight to laboratory-developed tests (LDTs). In a letter to Representatives Aaron Bean (R-FL) and Maxwell Frost (D-FL), Co-Chairs of the new House Delivering Outstanding Government Efficiency (DOGE) Caucus, ADLM urged Congress to take action against the rule, citing its potential to increase costs, duplicate existing regulations, and hinder patient care.

The agency’s final rule, issued in May 2024, subjects LDTs to the same regulatory framework as medical devices, despite the fact that LDTs are already regulated under the Clinical Laboratory Improvement Amendments (CLIA) by the Centers for Medicare & Medicaid Services (CMS).

ADLM warned that implementing this rule would:

  • Hinder innovation by discouraging the development of new LDTs, which are critical for advancing patient care.
  • Increase costs and limit access by imposing significant administrative and compliance burdens on laboratories, potentially forcing them to reduce or eliminate LDT offerings.
  • Duplicate existing regulation, creating unnecessary complexity without clear evidence of patient benefit.

The FDA’s push for this rule follows previous efforts that were halted during the Trump administration, when the Department of Health and Human Services (HHS) determined that the agency lacked authority to regulate LDTs. In 2022, Congress declined to grant the FDA explicit authority over LDTs, yet the agency moved forward with its own final rule, raising concerns about regulatory overreach.

ADLM emphasized that the FDA has yet to provide compelling evidence of a problem that justifies this expansion of oversight. The association is calling on the House DOGE Caucus to take action to revoke the rule and ensure patient access to vital diagnostic tests. ADLM remains committed to working with policymakers to promote regulatory policies that support innovation, efficiency, and high-quality patient care.