Challenges Posed by AI/ML-Enabled Devices May Require Congress To Give FDA New Authorities

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Challenges Posed by AI/ML-Enabled Devices May Require Congress To Give FDA New Authorities

Authority To Collect Performance Data, Reform of How the FDA Evaluates Devices May Be in the Works

Dennis Tosh

March 6, 2024 at 06:59 PM EST

A recent Government Accountability Office (GAO) report on the regulatory and legislative problems posed by emerging technologies offers a glimpse into possible upcoming changes in how the FDA authorizes and oversees medical devices that incorporate artificial intelligence (AI) or machine learning (ML) capabilities. The report — “Federal Regulation: Selected Emerging Technolog... Read More

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Challenges Posed by AI/ML-Enabled Devices May Require Congress To Give FDA New Authorities

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