The FDA is the bossy overlord of everything material that should ever come into contact with you and affect you, such as Food, Drugs and Cosmetics (Food, drugs and cosmetics act – Which I’m not paraphrasing or quoting verbatim).

Every medical device that is manufactured in the USA, right from cardiac pacemakers and orthopedic implants to surgical gloves, condoms and pregnancy test kits, comes under the purview of the FDnC act which is administered by the FDA. Diagnostic devices (instruments take readings from the body) such as the Fitbit, Apple watch, blood glucose monitors and mobile interfaced pulse-oximeters are touted as the new personal doctors.

While a pulse oximeter that measures your heart rate and oxygen saturation in your blood is subject to the stringent regulations of the FDA, the Apple watch which has a similar functionality is not. The difference arises in a seemingly benign statement called “Intended use”. The reason why a laser pointer used for presentations cannot be used along with an endoscope for tumor necrosis is simply because the manufacturer has not said so.

In a policy draft, the FDA referred to this glut of personal monitors in the market with the umbrella term of “General wellness devices”. As long as they are not marketed with the intended use of diagnosing health conditions, they are not under the purview of the FDA and are theoretically not medical devices. For example – The Apple watch’s heart rate feature is marketed with ONLY an intention of fitness tracking during an use case such as cycling or running.

Apple’s HealthKit SDK is also a wondrous exception for most people acquainted with the FDA which anecdotally is like a huge drop of water that seeks to coalesce with everything around it. FDA’s being really proactive about the domain of mobile medical apps, dedicating a section on it’s website to the topic and clearly laying out boundaries of regulations.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf

http://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/default.htm