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See today's BioWorld MedTech
Home » JAMA authors see problems with failures to acknowledge the use of AI in medical devices
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JAMA authors see problems with failures to acknowledge the use of AI in medical devices

July 10, 2023
By Mark McCarty
Device makers are often cited in U.S. FDA warning letters for making claims not seen in the approved labeling, but the authors of a recent review of artificial intelligence (AI) products cleared by the FDA suggest that FDA documents and marketing materials should disclose the presence of AI in these products. The authors of an article in the Journal of the American Medical Association said that only about 80.6% of the products were represented with accurate statements about the presence of AI, although FDA regulation does not require that marketing materials make such disclosures.
BioWorld MedTech Regulatory Medical devices Software Artificial intelligence Digital health U.S. FDA

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