The FDA Opens a Wider Door for Wellness Wearables | Haynes Boone

As Americans kick off the new year with resolutions to get fit, sleep better, and take better care of themselves, the FDA has broadened access to the wearable wellness device market to a greater number of products. In a related media interview, FDA Commissioner Marty Makary indicated that the FDA intends to let companies have very clear guidance that if a device is simply providing information, that can be done without FDA regulation. Still the same, however, is the need for marketers to carefully assess their products’ and their claims’ ability to safely fit within the parameters of the FDA’s guidance to avoid scrutiny or potential enforcement.