GlobalData 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 ...

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

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...
Fierce Healthcare

FDA paves way for more consumer wearables, AI-enabled devices to hit the market

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

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 ...
The American Bazaar

FDA moves to ease oversight of wearable health and wellness devices

Wearable health devices may soon operate under looser regulatory oversight following new guidance from the FDA ...
Arabian Business

FDA exempts non-medical-grade wearable data devices from regulation

These technologies are improving all the time. If they’re not making claims that they are medical grade, let’s let the market ...
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 ...
DataBreachToday

FDA Takes Hands-Off Approach to AI Devices and Software

New artificial intelligence-enabled health wearable devices and clinical decision support software will not face U.S. Food and Drug Administration regulatory ...
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 ...
PharmExec

FDA Limits Regulations on Non-Medical Grade Wearable Fitness Devices

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...
Forbes

FDA Medical Device Security SBOMs: While Great, Don’t Rely On Them Alone

The latest update to the Federal Drug Administration (FDA) for medical device cybersecurity mandates the development of a software bill of materials (SBOM). This provision can be a significant ...