Medical apps are not necessarily medical devices. The FDA only want to regulate those that are, but guidelines are various shades of gray.
There has certainly been a lot of hype lately (as in “Extravagant or intensive publicity or promotion”) about the role the FDA will have in regulation of medical apps for mobile devices. The draft guidance put out by the FDA on mobile medical apps (document 1741) at first seems very straight forward, but gets a bit more ambiguous the more you look into it.
Now I realize this is just “guidance”, but there are some potential implications to consider. Last year, a study came through our IRB that looked to implement the use of an iPhone app. While I won’t disclose the details of the study, I will say there was a bit of an urgency to read and better understand the guidance from the FDA for medical apps. As many researchers know, if they are using a tool or piece of equipment in their research that meets the definition of a “medical device” then it must be regulated by the FDA (Title 21 CFR). Their definition of a device is below and can include anything from a simple tongue depressor to a sophisticated robot that conducts surgery:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
– Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
– Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or,
– Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it’s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
See on medicalappjournal.com