Federal discussions about laboratory oversight entered a new phase this year following the end of FDA’s 2024 laboratory-developed test rule. A federal court vacated the rule, and FDA subsequently restored its in vitro diagnostic regulations to the framework that existed before the rule took effect. ADLM had opposed the FDA approach as duplicative and has continued supporting CLIA as the primary framework for clinical laboratory oversight.
Congress is also considering the Enhancing Clinical Laboratory Innovation and Access Act of 2026, or Enhancing CLIA Act, introduced by Rep. Neal Dunn, M.D. (R-Fla.). The bill would reaffirm CMS oversight of laboratory-developed testing services under CLIA and establish new mechanisms related to validation information, voluntary third-party review, and centralized error reporting. ADLM is reviewing the proposal with laboratory experts.
The broader CLIA modernization discussion accelerated in July when CMS and CDC issued a Request for Information seeking input on potential updates to the regulations. The RFI covers laboratory-developed and modified tests, next-generation sequencing, performance specifications, calibration verification, postanalytic interpretation and artificial intelligence, data-only facilities, laboratory personnel, remote competency assessment, cybersecurity, emergency preparedness, biosafety and biosecurity, specialty testing areas, and breath testing.
ADLM submitted a response with input from expert members. The association’s comments address how CLIA can better reflect current laboratory practices and emerging technologies while maintaining appropriate standards for quality, patient safety, and access to testing.