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

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20 hours ago

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

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.

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“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 (ABT.N), opens new tab, Medtronic (MDT.N), opens new tab and Dexcom (DXCM.O), opens new tab closed between 1% and 4% higher. U.S.-listed shares of fitness smartwatch maker Garmin (GRMN.BN), opens new tab 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.

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“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

Our Standards: The Thomson Reuters Trust Principles., opens new tab

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Fitness

Share your health and fitness questions for Devi Sridhar, Mariella Frostrup, and Joel Snape

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8 hours ago

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January 7, 2026

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Share your health and fitness questions for Devi Sridhar, Mariella Frostrup, and Joel Snape

There’s no bad time to take a more active interest in your health, but the new year, for lots of us, feels like a fresh start. Maybe you’re planning to sign up for a 10k or finally have a go at bouldering, eat a bit better or learn to swing a kettlebell. Maybe you want to keep up with your grandkids — or just be a little bit more physically prepared for whatever life throws at you.

To help things along, Guardian Live invites you to a special event with public health expert Devi Sridhar, journalist and author Mariella Frostrup, and health and fitness columnist Joel Snape. They’ll be joining the Guardian’s Today in Focus presenter Annie Kelly to discuss simple, actionable ways to stay fit and healthy as you move through the second half of life: whether that means staying strong and mobile or stressing less and sleeping better.

To make the whole event as helpful as possible, we’d love to hear from you about what you find most challenging — or confusing — when it comes to health and exercise. What should you actually be eating, and how are you going to find the time to make it? What sort of exercise is best, and how often should you be doing it? Is Pilates worth the effort — and should we really all be drinking mugfuls of piping hot creatine?

Whether your question is about exercise, eating, or general wellness, post it below and we’ll put a selection to our panel on the night.

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