FDA exempts more wearable, AI features from oversight

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
Medical Device and Diagnostic Industry (MD+DI)Opinion

FDA's Deregulation of Wellness Devices Is a Slippery Slope

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...
Medical Device and Diagnostic Industry (MD+DI)

FDA’s New Rules for Wearables

FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
Fierce Healthcare

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

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

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.
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 ...
JD Supra

FDA Seeks Guidance from the Digital Health Advisory Committee on AI: Considerations for Innovators of Digital Mental Health Medical Devices and Wellness Products

On Nov. 6, the Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) convened to discuss the promise and evolving challenges of Generative Artificial Intelligence ...
JD Supra

FDA's Digital Health Advisory Committee Discusses Total Product Lifecycle Considerations for GenAI-Enabled Devices

The Situation: While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and complexities that challenge the U.S. Food and Drug ...