FDA wants public input on AI-enabled device regulation

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(Image from FDA)

The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared. It is also asking for the public’s feedback.

To date, the agency has cleared or approved AI/ML-assisted devices whose algorithms have typically been locked before hitting the market. The FDA’s 20-page discussion paper includes a proposed regulatory framework for devices that have algorithms that can learn and change after the devices have been sold.

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