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 ...
EconoTimes

FDA Limits Regulation of Wearable Devices and Wellness Software, Boosting Health Tech Industry

The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will limit regulatory oversight of wearable devices ...

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

The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
Becker's Hospital Review

FDA: Nonmedical wearable health data won’t face oversight

FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for tech companies and investors.
American Hospital Association

FDA issues guidance on wellness products, clinical decision support software

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
STAT

FDA announces sweeping changes to oversight of wearables, AI-enabled devices

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
MobiHealthNews

Commentary: FDA’s website has wrong information about the scope of its software regulation — and that's a big problem

8. Guidance document: Off-The-Shelf Software Use in Medical Devices FDA itself has said that section 3.2.2 of this guidance is out-of-date because it characterizes laboratory information management ...
Forbes

Are The FDA’s New Regulations On Medical Devices Making A Difference?

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...