Advocacy - Lab Advocate
On November 12, 2025, the Association for Diagnostics & Laboratory Medicine (ADLM) submitted comments to the U.S. Food and Drug Administration (FDA) on the agency’s efforts to develop a regulatory framework for medical devices that utilize artificial intelligence (AI).
In its letter, ADLM highlighted the parallels between AI oversight and the quality systems used in clinical laboratory testing, emphasizing that lessons from CLIA-based validation, quality control, and external proficiency testing can inform FDA’s approach. ADLM recommended that AI tools used in laboratory settings undergo validation and verification protocols aligned with the risk and intended use of each system. The association also urged FDA to incorporate clinical laboratorians in the oversight process, particularly for AI algorithms involved in ordering and interpreting laboratory tests, where data harmonization and bias mitigation are critical.
ADLM remains committed to ensuring that AI technologies in laboratory medicine are safe, effective, and transparent, and that their regulation reflects real-world laboratory practice.