FDA Enhances Innovation by Relaxing Regulations on Health Wearables
The U.S. Food and Drug Administration (FDA) unveiled a significant shift in its regulatory approach on January 6, 2026. This change eases the oversight on wearable health devices and wellness software, aiming to foster innovation while upholding patient safety standards.
FDA Commissioner, Marty Makary, announced these changes at the Consumer Electronics Show (CES) in Las Vegas. He emphasized that the agency needs to move at “Silicon Valley speed.” With the new guidance, devices and software that offer general health information—instead of clinical-grade measurements—can now function without FDA oversight.
The revised policy is applicable to fitness applications, activity trackers, and wearables that promote exercise or provide wellness information. However, this is contingent on the fact that they don’t make medical-grade claims. Products purporting to provide diagnostic-level measurements, such as clinical blood pressure readings, will still necessitate FDA regulation. The market reacted positively to this news, with shares of companies like Abbott, Medtronic, Dexcom, and Garmin witnessing a rise between 1% and 4%.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” Makary stated. He stressed the importance of striking a balance between encouraging innovation and safeguarding against safety concerns.
Source: www.statnews.com