This blog article is a bit different than others, as it is a news update that I wanted to share with those who are in, or considering getting into, the business of wearable devices. On Jan 20, 2015, the FDA (Food & Drug Administration) released a draft of new guidance policy governing wearables that monitor health or fitness. This is still just a draft, and its open for public comment, but familiarizing yourself with it can help you prepare for the upcoming changes.
Note a few things about this policy draft. They come up with a definition for “General Wellness Products”
(1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition).”
The draft states that the FDA won’t be focused on regulating these type of “General Wellness Products.” Therefore, products that track general sleeping exercising habits, or products that claim they help with stress (but not anxiety) won’t have to get FDA approval first. However, once your business starts claiming that your wearable device cures or treats diseases, such as obesity or Attention Deficit Disorder, then the FDA will regulate the claims.
The draft also addresses the invasiveness of the device, allowing regulation of those devices inserted within the body or poses a safety risk, but generally not those that are easily removable and worn as accessories.
The FDA website offers the draft to review.