Wellness Devices May Have More Leeway In FDA Final Guidance

02 Aug 2016

As new mobile health technologies such as wearables and mobile health apps come to market, the US FDA's new guidance is intended to give manufacturers a better idea of what kinds of low-risk wellness products the agency will allow to avoid regulation.

FDA appears to have added more leeway for firms making "wellness" products to avoid active regulation in a newly finalized guidance document, according to industry experts.

FDA's guidance document on "General Wellness: Policy for Low-Risk Devices" was finalized from a January 2015 draft version...