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FDA Says AI Regulations May Require More Congressional Authorities

The top official on artificial intelligence products at the US FDA says that while the agency has some authorities to implement regulatory oversight, it may need additional powers from Congress considering the direction the FDA may possibly take in regulating AI and machine learning products.

Behtany Hills and Bakul Patel
Life science attorney Bethany Hills and the FDA's Bakul Patel at the 2019 World Medical Innovation Forum in Boston • Source: Ferdous Al-Faruque

As medtech artificial intelligence and machine learning (AI/ML) programs are expected to boom in the near future, the US Food and Drug Administration is racing to develop regulations. According to a top FDA official, while the agency has some authority to regulate such products, it may require more authorities from Congress to achieve the kind of regulatory oversight that’s needed.

The FDA held a two-day multi-stakeholder workshop late last month at the National Institutes of Health (NIH) in Bethesda, MD, to gain critical feedback that can help the agency develop...

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