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Navigating regulatory and policy challenges for AI enabled combination devices.

PMID: 39669903 · 2024-11-28

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ZeitschriftFrontiers in medical technology

Jahr2024-11-28

PMID39669903

Zusammenfassung

In recent years, the Artificial Intelligence (AI) has enabled conventional Combination Devices (CDs) to innovate in healthcare merging with technology sectors. However, the challenges like reliance on predicate devices in US Food and Drug Administration (FDA's 510(k) pathway, especially for perpetually updating AI are stressed. Though the European Union (EU's new Medical Device Regulations address software and AI, fitting adaptive algorithms into conformity assessments remains difficult. The urg

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