FDA Draft Guidance Reshapes AI Device Compliance
The FDA issued new draft guidance on August 11, 2026 for postmarket performance monitoring of AI/ML‑enabled Software as a Medical Device, tightening oversight of clinical AI after deployment. The guidance requires approved AI products, including those used in imaging, molecular diagnostics, and pathology, to implement mechanisms for real‑time performance drift alerts, clinical feedback loops, and cross‑institution data aggregation to support ongoing safety and effectiveness.
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LOG Standards provides an independent accreditation signal for AI models used in healthcare, helping hospitals, care networks, and AI companies bring clinical AI readiness and governance into clearer conversations.
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