The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...
MedPage Today on MSNOpinion
Easing AI and Wearables Regulation Is a Risky Move
Guidance is not law, and frameworks should evolve. But the symbolism matters. At a moment when AI is entering clinical ...
As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that ...
Pulsetto Bilateral Cervical Neuromodulation Device Evaluation: Session Duration, General Wellness Positioning, User-Reported Experience Patterns, and Drug-Free Stress Support Use Case Documentation ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The Oura Ring isn’t FDA approved as a medical device. It’s considered a general wellness product. This means it’s designed ...
The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of ...
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