By Puyaan Singh
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.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” Makary told Fox Business.
“The only stipulation is if they make claims of something being medical grade … like blood pressure measurement. We don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiologic parameter.”
Last year, the FDA issued a warning letter to fitness band maker WHOOP, saying its blood-pressure insights feature blurred the line between wellness and medical devices by estimating systolic and diastolic values used to diagnose hypertension.
The agency also sent out a broader warning to consumers about the risks posed by unauthorized devices.
(Reporting by Puyaan Singh in Bengaluru; Editing by Peter Henderson and Sherry Jacob-Phillips)
