The Food and Drug Administration on Jan. 6 clarified that it will not regulate some artificial intelligence (AI) tools and wearables.
https://www.fda.gov/media/109618/download
Tools used to help make clinical decisions are sometimes exempt from FDA oversight, such as those not intended to analyze medical images.
The FDA said it does not regulate “low risk products that promote a healthy lifestyle,” including “low risk general wellness products” such as exercise equipment and software programs.
