A Rose by Any Other Name Just Might Be a Medical Device
On September 25, 2013 the Food and Drug Administration (FDA)
issued its final Guidance on Mobile Medical Applications
(medical apps) to inform manufacturers, distributors, and other
entities about how the FDA intends to apply its regulatory
authority over software applications on mobile platforms (mobile
apps). Under the Guidance, the FDA will apply its
regulatory oversight to those medical apps that are "medical
devices" and whose "functionality" could pose a risk
to patient safety if the medical app does not function as
intended.
Under the Guidance, the FDA regulates software applications that
are run on a "mobile platform" (i.e. a commercial
off-the-shelf (COTS) computing handheld platform such as a smart
phone, tablet computer, or portable computer) that are
"intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of
disease" and are intended to be used as an accessory to a
regulated medical device or to transform a mobile platform into a
regulated medical device.
A rose by any other name is a regulated device.
The intended use of a medical app determines whether it is a
medical device. Under the Food, Drug, and Cosmetic Act
(FDCA), the phrase "intended use" refers 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... 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 FDA provides an example of an app that makes a light emitting diode (LED). If the manufacturer intends the system to illuminate objects generally, the mobile app would be a light. If 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 app would be as a medical device, which would be regulated similar to an ophthalmoscope.
Who is a "Manufacturer"?
Examples of mobile medical app manufacturers include any person
or entity that:
- creates, designs, develops, labels, re-labels, remanufactures, modifies, or creates a mobile medical app software system from multiple components;
- initiates specifications or requirements or procures product development/manufacturing services from other individuals or entities (second party) for subsequent commercial distribution;
- creates a mobile medical app and hardware attachments for a mobile platform; or
- creates a mobile medical app or a software system that provides users access to the medical device function through a website subscription, software as a service, or other means.
Physicians, But Not Commercially Distributing? Don't Worry Be Appy
The FDA also says that it does not intend to apply oversight
authority over manufacturers who are licensed healthcare providers
concerning a medical app that is used "solely for use in their
professional practice and [where the providers] do not label or
promote their mobile medical apps to be generally used" by
others. The FDA provides the following illustration: "if
Dr. XYZ, the licensed practitioner, distributes the XYZ-recorder
and, through labeling or promotion intends to make it generally
available to or to be generally used by other physicians (or other
specially qualified persons), Dr. XYZ would be considered a mobile
medical app manufacturer."
The FDA also intends to exercise enforcement discretion (i.e.
not enforcing) for medical apps:
i) used in research, teaching or analysis; and ii) used by
patients without active oversight by a medical professional and
where use of the app is not intended to replace or discourage the
user from seeking treatment from a healthcare provider.
Further limiting the FDA's reach, on October 23, 2013 the
House introduced H.R. 3303: Sensible Oversight for Technology which
Advances Regulatory Efficiency Act of 2013. This proposed
legislation would exclude "clinical software" and
"health software" from regulation under the FDCA as
medical devices. Clinical software and health software are
defined under the proposed legislation as administrative,
operational or a mechanism to store data, provided the medical app
is marketed for use by health care providers in a "health care
setting."
Clinical Studies Involving Medical Apps
Any clinical study involving medical apps must be approved by
the FDA and by an Institutional Review Board (IRB)
before the study can begin. Studies involving medical apps
that do not pose a significant risk must be approved only by an IRB
before the study can begin. Determining whether FDA approval
is required should be addressed directly with the FDA.
Compliance – There is No App For That
Regardless of whether a medical app is subject to the premarket
submission requirements, all medical devices are subject to what
the FDA terms "General Controls." In all events,
regardless of the device classification or whether the FDA will
exercise enforcement discretion, the Medical Device Reporting
regulations require manufacturers and importers to submit reports
to the FDA whenever they become aware of information that
"reasonably suggests" that a device they market may have
caused or contributed to or would be likely to cause or contribute
to a reportable death or serious injury if a malfunction were to
occur.
Those who create applications that are used in rendering healthcare should be sure to have a third party review whether and where its products fall under the FDA's scheme for the regulation of medical devices because the FDA is watching.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.