The AOA submitted comments to the FDA on its proposed guidance for marketing submissions of artificial intelligence (AI)-enabled medical devices. The AOA supports the FDA’s efforts to promote innovation and improve patient care through AI but urges stronger safeguards to ensure transparency, reduce bias and protect patients.
Key recommendations include making several voluntary guidance elements—such as detailed device descriptions, risk assessments and data management protocols—mandatory. The AOA calls for clearer labeling that discloses the data used to train AI tools, including demographics and geographic scope, to help physicians assess appropriateness for their patient populations.
The AOA also encourages the FDA to strengthen validation and post-market monitoring requirements, noting that bias and underperformance often emerge after deployment. Without adequate oversight, state-level patchwork regulation could increase costs and hinder innovation. To foster trust and adoption, the AOA advocates for improved transparency, equity and performance standards throughout the AI device lifecycle. The AOA remains committed to collaborating with the FDA to ensure safe, reliable AI integration in health care.
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