JD Supra

FDA’s 2026 Guidance on General Wellness Devices: Policy for Low-Risk Devices

This three-part series reviews how the Food and Drug Administration’s (FDA) January 2026 guidance, “General Wellness: Policy for Low Risk ...
JD Supra

FDA Town Hall Sheds New Light on Updated General Wellness Policy - DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care

On February 11, 2026, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) held a Town Hall to address industry questions and provide further clarity on the ...
MobiHealthNews

FDA clarifies the line between wellness and regulated medical devices

As promised in its FDASIA report, the FDA has published a draft guidance document that aims to help those creating wellness devices and apps to better understand when their product (or their marketing ...
Law

As Wearable Wellness Gear Proliferates, Companies Struggle to Figure Out When They Need the FDA's Blessing

“The FDA process is time-consuming and costly. There’s no reason to do it if your product is not going to cross the line," said Ariel Seeley, a Morgan, Lewis & Bockius partner. The explosion in recent ...
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 wellness category and skip the agency's expensive review process before going to ...
BioWorld

FDA’s new general wellness guidance is no dramatic overhaul

The U.S. FDA’s reissuance of the 2019 guidance for general wellness products seems to carve out new territory for makers of wearables that make modest claims regarding health, but anyone who was ...