Unless you’re a devoted reader of the Federal Register, you may have missed the Food & Drug Administration’s recent guidance about what the agency really cares about when it comes wearable technology. The guidance, titled “General Wellness: Policy for Low Risk Devices,” is meant not only for the wearables industry, but for FDA staff in the Center for Devices and Radiological Healths (CDRH).
Essentially, the FDA says it will not examine “low-risk general wellness” products. It seems to boil down you’re being OK if:
- you can buy your product or download it at retail;
- you’re not targeting a specific disease but rather things like weight or stress management, fitness, mental acuity, or sexual wellness; and
- the product encourages a healthy lifestyle which is “well understood” to reduce the risk or impact of chronic conditions.
So a device that promotes mental sharpness is OK; one that says it prevents Alzheimer’s Disease will have some explaining to do.
Moreover, anything that requires implantation, or things that might pose a risk to safety if controls are not applied (the guidance mentions lasers or radiation exposure), you’ll need FDA approval.
Comments should be submitted by April 20, 2015 to www.regulations.gov, Docket Number FDA-2014-N-1039.