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, ...
FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...
Facet Life Sciences, a regulatory affairs and product development strategy partner, is proud to announce the release of the second edition of FDA and Intellectual Property Strategies for Medical ...
Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.
IEEE Spectrum on MSN
What the FDA’s 2026 update means for wearables
Simpler rules apply to less invasive hardware ...
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 ...
FDA plans to limit the regulation of wearable medical devices, according to a January 6 notice from the agency. Currently, the majority of fitness tracking wearables and fitness apps are classified as ...
Medical Device Network on MSN
Sonorous receives FDA breakthrough designation for BosSTENT device
BosSTENT is a braided stent with enhanced radiopacity, resheathability, and conformability for complex neurovascular anatomy.
For most implants and other high-risk devices brought to market, manufacturers do nothing more than file some paperwork and ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices. Officials say the move is intended to speed innovation while maintaining ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results