Lexology April 12, 2024
AI Integration Has Revolutionized the Health Care Industry
The integration of artificial intelligence (AI) and machine learning (ML) into medical devices has revolutionized health care, enabling advancements in patient diagnosis, treatment personalization and management.
This technological evolution, however, introduces challenges in regulatory compliance and product liability that necessitate a nuanced approach to ensure patient safety without hindering innovation. In April 2023, the U.S. Food and Drug Administration (FDA) responded to these challenges by issuing a draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” The draft guidance aims to facilitate the safe and effective iterative improvement of AI/ML technologies, termed as machine learning-enabled device software functions (ML-DSF), within medical...
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