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FDA signals less regulation for wearable devices, AI providing non-medical information

A detailed view of a referee's Apple Watch.
Photo: Chris Tanouye/Freestyle Photography/Getty Images

Kevin Kinsella

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According to new guidance, certain devices and software that track metrics such as heart rate and activity level will require less rigorous pre-market reviewal.

Through the issuance of two guidance documents on January 6, the US Food and Drug Administration (FDA) indicated it will limit the regulation of wearable devices that provide non-medical information as well as rules on clinical decision support software such as ChatGPT.

FDA Commissioner Marty Makary announced the new documents on

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