FDA commissioner says non-medical-grade wearable data exempt from regulation

FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health technology and AI policies.

FDA Eases Wearable Oversight: Industry Leaders React at Newsweek Event

Looser regulations around consumer-grade wearable devices could be a "path to ROI" for health systems—or a "double-edged ...
Medical Device Network on MSN

FDA announces regulatory exemptions for 'non-medical grade' devices

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less regulatory oversight.
Medical Device and Diagnostic Industry (MD+DI)

CGM Manufacturer Views FDA’s New Rules on Wearables as “Catalyst” for Accelerated Commercialization

Woori IO plans to accelerate its noninvasive CGM launch after FDA announced relaxed wearable device regulations.

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

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 ...
Medical Device and Diagnostic Industry (MD+DI)

How Medical Device Companies Can Avoid Costly FDA Inspection Mistakes

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
CounterPunch

The FDA Fails to Protect Americans from the Medical Device Industry

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...
Healthline

Which Products Does the FDA Regulate?

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...
Yahoo

FDA announces regulatory exemptions for ‘non-medical grade’ devices

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...