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FOR IMMEDIATE RELEASE Association for Pathology Informatics (API) Submits Public Comment to FDA on Real-World Performance of AI-Enabled Medical Devices [December 2, 2025] — The Association for Pathology Informatics (API) has submitted formal comments to the U.S. Food and Drug Administration (FDA) in response to Docket No. FDA-2025-N-4203, “Measuring and Evaluating AI-Enabled Medical Device Performance in the Real World.” The letter reflects API’s expertise in clinical pathology, laboratory medicine, digital diagnostics, and informatics, offering recommendations to strengthen FDA’s developing framework for AI oversight. API commends the FDA’s efforts to ensure safety, reliability, and transparency of AI systems across their lifecycle, particularly in real-world environments where models encounter population shifts, workflow differences, and evolving practice patterns. Key Themes:
The organization also highlights several regulatory gaps, including liability, billing and reimbursement, AI autonomy and supervision, transparency, and modularity in digital pathology components. “Artificial intelligence is elevating pathology and laboratory medicine by supporting more accurate, efficient, and timely diagnostics. Ensuring these technologies operate safely, effectively, and equitably in real-world clinical settings is essential,” said Lisa-Jean Clifford, President of the Association for Pathology Informatics. You can view the letter on the API web site at https://www.pathologyinformatics.org/api-positions-and-papers-and-expertise About API: The Association for Pathology Informatics is the leading professional organization dedicated to advancing informatics in anatomic pathology, clinical pathology, and laboratory medicine. Learn more at www.pathologyinformatics.org. Media Contact: |