Of interest, medical device consultant, Leonard Eisner an IEC 60601-1 expert, Regulatory, Product Safety, Compliance, Quality System, & Internal Audits expert provides some insight on guidance documents available to help you determine if your Wearable device is a medical device that needs FDA approval or not for US submissions. http://www.eisnersafety.com/wearables-the-rage-but-are-they-medical-devi...