While mobile health apps and wearable devices have become exponentially more popular, FDA has explained they will not be regulating “low risk” general wellness devices. Traditionally, medical devices are required to obtain FDA approval or provide evidence of similarity to a preexisting product. In a new draft guidance entitled General Wellness: Policy for Low Risk Devices, the Agency has confirmed their decision not to regulate products classified as “low risk general wellness.” FDA defines such products as “solely intended for a general audience and presenting a very low risk to users’ safety.” Some examples provided in the guidance include exercise equipment, sleep, stress, or weight management devices, and other physical fitness products intended for recreational use.
For more information, read Alexander Gaffney’s article on RAPS.org here.