FDA Will Not Regulate Low-Risk General Wellness Devices

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) recently issued a final guidance document General Wellness:  Policy for Low-Risk Devices.  The FDA CDRH will not “actively regulate low-risk technologies that are intended only for general wellness use,” and “encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health.”  The FDA CDRH will continue to regulate “medical devices that may pose inherent risks to a user’s safety.”  General wellness products will not be considered “low risk” if the product is invasive, implanted, or involve technology with potential risks from lasers, radiation exposure, or electrical stimulation.  The FDA is conducting a webinar on September 1, 2016 to provide further information, and answer participants’ questions, on its policy for low-risk general wellness devices.  For additional information, see the FDA Announcing the General Wellness:  Policy for Low-Risk Devices Final Guidance page.