Advocacy - Comment Letter
On November 12, ADLM submitted comments to the Food and Drug Administration (FDA) on its September 30th request for public comment on “Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World,” as the agency continues to explore a regulatory approach for artificial intelligence (AI) technologies used in laboratories and similar healthcare settings. In the letter, ADLM recommended that AI oversight align with existing laboratory quality systems, which already include rigorous validation, verification of performance characteristics, defined reportable ranges, reproducibility checks, and ongoing quality control.
ADLM underscored that laboratorians are uniquely positioned to assess how AI tools integrate into testing workflows and influence patient results. The association stated that regulatory expectations should support innovation, transparency, and continuous performance monitoring while recognizing the expertise embedded within clinical laboratory practice.
ADLM will continue to engage with policymakers to ensure that emerging AI oversight frameworks enhance patient safety and diagnostic quality.