United States: FDA Regulation Of Medical Apps – Don’t Worry Be Appy

Last Updated: November 2 2013
Article by Michael A. Walsh

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.

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