FDA Moves to 'Get Out of the Way' of Wearables, AI in the Clinic

FDA Moves to 'Get Out of the Way' of Wearables, AI in the Clinic

(MedPage Today) -- At the Consumer Electronics Show in Las Vegas, FDA Commissioner Marty Makary, MD, MPH, announced that his agency issued two new guidance documents aimed at easing regulation of digital health products. Both guidance documents...

FDA Says Many Fitness Wearables, AI Tools Exempt From Regulation

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FDA exempts more wearable, AI features from oversight

The regulator clarified the types of wellness features and clinical decision support tools that don’t fall under medical device oversight in a pair of new guidance documents.