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“Risky Business Of FDA Mobile Medical Apps”

Law360 By Jennifer J. Hennessy

The U.S. Food and Drug Administration has issued final guidance[1] on mobile medical applications, which are mobile apps that meet the definition of a device[2] 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. Mobile apps are software applications that are run through mobile platforms (e.g., smartphones, tablet computers and other handheld computing platforms) or certain web-based software applications.

The final guidance states that the FDA will apply its regulatory authority oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to the patient's safety if the mobile app were to not function as intended.

Accordingly, while some mobile apps may technically meet the definition of a "device," the FDA will exercise enforcement discretion if those apps pose a lower risk to the public.

The final guidance provides examples of the type of mobile apps that the FDA does not consider to be devices, mobile apps that are devices but for which the FDA will exercise enforcement discretion because it views the devices as low risk and lastly, mobile apps on which the FDA intends to focus its regulatory oversight. We address each of these below in turn.

When is a Mobile App a Medical Device?

A mobile app will be considered a device if it is intended to perform a medical-device function, that is, if its intended use 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 FDA states that the function of the mobile app, not the platform on which it runs, is the focus. However, the FDA notes that the safety of a particular mobile app may be impacted by the platform on which it is run (e.g., a small screen may increase safety risks), and such risks will be taken into account when the FDA determines the appropriate oversight for the mobile app.

Further, the FDA provides multiple examples of the types of products it does not consider to be devices, such as mobile apps that:

  • Are intended to provide electronic copies of reference materials (e.g., medical dictionaries)
  • Are intended for health care providers to use as educational tools for medical training (e.g., medical flash cards, surgical training videos)
  • Are intended for general patient education and to facilitate patient access to commonly used reference information (e.g. provide portal for provider to distribute educational information to patients)
  • Automate general office operations in a health care setting (e.g., determine billing codes)
  • Are generic aids or general purpose products (e.g., magnifying glasses)

Will the FDA Exercise Enforcement Discretion over the Device?

The final guidance states that the FDA plans to exercise enforcement discretion (i.e., not focus its regulatory oversight) over mobile medical apps that fulfill one of the following six purposes:

  • Help patients self-manage their disease or conditions without providing specific treatment or treatment suggestions
  • Provide patients with simple tools to organize and track their health information
  • Provide easy access to information related to patients’ health conditions or treatments
  • Help patients document, show or communicate potential medical conditions to health care providers
  • Automate simple tasks for health care providers
  • Enable patients or providers to interact with personal health record or electronic health record systems.

The final guidance provides additional detail and examples of each of these categories.

In contrast, the FDA states it will focus its regulatory oversight on mobile medical apps that:

  • Transform a mobile platform (such as a smartphone) into a regulated medical device by using attachments, display screens or sensors or by including functionalities similar to those of currently regulated medical devices (e.g., mobile apps that use an attachment to the mobile platform to measure blood glucose levels). These apps may use the mobile platform's built-in features (e.g., light or camera) to perform medical device functions.
  • Connect to an existing device type for purposes of controlling its operation, function or energy source (e.g., mobile apps that control the inflation or deflation of a blood-pressure cuff or control the delivery of insulin on an insulin pump by submitting control signals to the pumps from the mobile platform)
  • Display, transfer, store or convert patient-specific medical device data from a connected device (e.g., mobile apps that connect to a nursing central station and display medical device data to a physician’s mobile platform for review)
  • Perform patient-specific analysis and provide patient-specific diagnosis or treatment recommendations (e.g., radiation therapy treatment planning software)

To determine whether a particular product is a type of device over which the FDA will focus its regulatory oversight, manufacturers should compare their product to the examples provided in the final guidance. Manufacturers will need to determine whether the product is similar in intended use and level of risk to those products that the FDA lists as examples of the types of products over which it will exercise enforcement discretion or alternatively, similar in intended use and level of risk to the type of products over which the FDA will focus its regulatory oversight.

The FDA Plans to Focus its Regulatory Authority on My Mobile App. Now What?

If the FDA considers the device to be subject to FDA regulatory oversight, the mobile app manufacturer must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification (Class I, II or III), the manufacturer must follow the requirements associated with that classification.


The FDA has issued this guidance to assist mobile medical app manufacturers in determining how the FDA will regulate mobile medical apps. Importantly, this final guidance applies to mobile medical device manufacturers. It is not intended to regulate the sale or general use of smartphones or similar products or does it restrict distributors of mobile apps (i.e., iTunes).

Lastly, the FDA’s mobile medical app final guidance does not apply to mobile apps that function as an electronic health record system or personal health record system.

--By Jennifer J. Hennessy and Lisa E. Davis, Quarles & Brady LLP

Jennifer Hennessy is an associate in the firm's Madison, Wis., office. Lisa Davis is a partner in the Phoenix office.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] Mobile Medical Applications, Guidance for Industry and Food and Drug Administration Staff, Sept. 25, 2013,

[2] See 21 U.S.C. § 321(h), defining "device" as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) 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 (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its 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 its primary intended purposes. 

Originally published in Law360, October 31, 2013