Contains Nonbinding Recommendations
6
The intended use of a mobile app determines whether it meets the definition of a “device.”
As stated in 21 CFR 801.4,
intended use may be shown by labeling
claims, advertising
materials, or oral or written statements by manufacturers or their representatives. When the
intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure,
mitigation, treatment, or prevention of disease, or is intended to affect the structure or any
function of the body of man, the mobile app is a device under section 201(h) of the FD&C
Act if it is not a software function excluded from the device definition by section 520(o) of
the FD&C Act.
One example is a mobile app that makes a light emitting diode (LED) operate. If the
manufacturer intends the system to illuminate objects generally (i.e., without a specific
medical device intended use), the mobile app would not be considered a medical device. If,
however, through marketing, labeling, and the circumstances surrounding the distribution,
the mobile app is promoted by the manufacturer for use as a light source for doctors to
examine patients, then the intended use of the light source would be similar to a conventional
device such as an ophthalmoscope.
In general, if a software function is intended for use in performing a medical device function
(i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or
prevention of disease), it is a medical device, regardless of the platform on which it is run.
For example, mobile apps intended to run on smart phones to analyze and interpret EKG
waveforms to detect heart function irregularities would be considered similar to software
running on a desktop computer that serves the same function, which is regulated under 21
CFR 870.2340 (“Electrocardiograph”). FDA’s oversight approach to software functions is
focused on their functionality, just as we focus on the functionality of conventional devices.
Our oversight is not determined by the platform. Under this guidance, FDA would not
regulate the sale or general/conventional consumer use of smartphones or tablets. FDA’s
oversight applies to software functions performing medical device functions, such as when a
mobile medical app or software application transforms a mobile platform or a general
purpose computing platform into a medical device. However, as previously noted, we intend
to apply this oversight authority only to those software applications whose functionality
“The words ‘intended uses’ or words of similar import … refer to the objective intent of the persons legally
responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown
by the circumstances surrounding the distribution of the article. This objective intent may, for example, be
shown by labeling claims, advertising matter, or oral or written statements by such persons or their
representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or
their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended
uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for
example, a packer, distributor, or seller intends an article for different uses than those intended by the person
from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in
accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give
him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or
uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device
which accords with such other uses to which the article is to be put.” 21 CFR 801.4.
“The term ‘labeling’ means all labels and other written, printed, or graphic matter (1) upon any article or any
of its containers or wrappers, or (2) accompanying such article.” Section 201(m) of the FD&C Act, 21 U.S.C.
321(m).