PubMed

Regulatory considerations for medical imaging AI/ML devices in the United States: concepts and challenges.

PMID: 37361549 · 2023-06-23

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ZeitschriftJournal of medical imaging (Bellingham, Wash.)

Jahr2023-06-23

PMID37361549

Zusammenfassung

To introduce developers to medical device regulatory processes and data considerations in artificial intelligence and machine learning (AI/ML) device submissions and to discuss ongoing AI/ML-related regulatory challenges and activities. AI/ML technologies are being used in an increasing number of medical imaging devices, and the fast evolution of these technologies presents novel regulatory challenges. We provide AI/ML developers with an introduction to U.S. Food and Drug Administration (FDA) re

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