US FDA to limit regulation of health and fitness wearables, commissioner says

Source: msn/Reuters

12h


Jan 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed to support healthy lifestyles, issuing new guidance to clarify its regulatory approach.

The guidance, along with comments from FDA Commissioner Marty Makary, adds to existing policy that classifies low-risk wellness tools, such as fitness apps and activity trackers that encourage exercise, as non-medical devices exempt from stringent regulation, provided they do not make claims related to disease diagnosis or treatment.

"We have to promote these products and at the same time, just guard against major safety concerns," Makary said in an interview with Fox Business about artificial intelligence software such as ChatGPT, adding that "if people are looking up a symptom on an AI-based tool, let's have that conversation when they come in to see their doctor or do a virtual visit."

Shares of continuous glucose monitor manufacturers Abbott, Medtronic and Dexcom closed between 1% and 4% higher. U.S.-listed shares of fitness smartwatch maker Garmin ended nearly 3% higher.

Read more: https://www.msn.com/en-us/technology/software/us-fda-to-limit-regulation-of-health-and-fitness-wearables-commissioner-says/ar-AA1THOJi