FDA Eases Wellness Device Regulation, But Marketing Is Still Key

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...
Medical Design & Outsourcing

FDA’s new guidance on consumer wearables makes the medtech market more complex

Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.
Hosted on MSN

Device claims to protect athletes’ brains, but records reveal doubts at FDA

“The FDA’s medical experts made a thorough evaluation of the data and made the right call on the benefits outweighing the little to no risk of wearing the Q-Collar.” The BMJ paper, published by two ...
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 ...
MD&M East

FDA's Deregulation of Wellness Devices Is a Slippery Slope

Like many in the medtech industry, I was initially optimistic when FDA announced its revised guidance on wearable wellness devices. For years, the industry has called for clearer, more predictable ...
HealthLeaders Media

FDA relaxes rules for wearable health devices

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

Dangerous medical implants and devices

For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...