I would still say no, the fitbit does not need to be regulated. The CDRH defines a general wellness product as “Products that are intended for only general wellness use and present a low risk to the safety of the user.” The fitbit is a good estimate and accurate to an extent but there’s a reason a doctor will still take their own reading instead of looking at your watch. Because the fitbit is not a medical device, nor does it claim to be. The fitbit is used to promote healthy activity, it does not state claims of life sustaining or improving health. It also does not pose a significant risk to the user. Although the guidelines have changed, I still think regulation would be reserved for those that are determined a medical device.