On July 21, 2011, the U.S. Food and Drug Administration (FDA) gave notice1 that it is seeking input on its proposed oversight approach for certain mobile applications specific to medicine or health care called “mobile medical applications” (apps), which are designed for use on smartphones and other mobile computing devices such as tablets or PDA’s. According to the FDA press release:

This approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets [...] Today, mobile medical applications include a variety of functions, ranging from monitoring calorie intake, helping people maintain a healthy weight, and allowing doctors to view a patient’s radiology images on their mobile communications device. Moreover, according to Research2Guidance 2010, 500 million smartphone users worldwide will be using healthcare applications by 2015 [...] According to Jeffery Shuren, MD., JD., director of the FDA’s Center for Device and Radiological Health, “The draft guidance calls for oversight of only those medical mobile apps that present the greatest risk to patients when they don’t work as intended.”  

The guidance defines a small subset of apps that impact or may impact the performance or functionality of currently regulated medical devices. The subset includes mobile medical apps that:

  1. Are used as an accessory to medical devices already regulated by FDA; or
  2. Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.

Introduction

The FDA is issuing this draft guidance to inform manufactures, distributors, and other entities about how the FDA will regulate select software applications intended for use on mobile platforms. According to the draft guidance, “the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or ‘mobile medical apps.’”

Background

There is a growing range of software applications being developed for smart phones, tablet computers, and personal digital assistants. A plethora of these mobile apps are being targeted to help individuals in their own health care. Other mobile apps are being targeted to assist healthcare providers to improve the delivery of patient care.  

As early as 1989, FDA prepared a general policy statement on how it was going to determine whether a computer based product and/or software based product is a device, and if so, how the FDA intended to regulate it. Subsequently, the use of computer and software products as medical devices grew at an extraordinarily high rate, and the types of products diversified and became more complex. As a result, the draft software policy was withdrawn. According to the draft guidance:  

Although the FDA has not issued an overarching software policy, the Agency has formally classified certain types of software applications that meet the definition of a device and, through classification, identified specific regulatory requirements that apply to these devices and their manufacturers. These software devices include products that feature one or more software components, parts, or accessories (such as electrocardiographic (ECG) systems used to monitor patient activity, as well as devices that are composed solely of software (such as laboratory information management systems)). On February 15, 2011, the FDA issued a regulation down-classifying certain computer-or software based devices intended to be used for the electronic transfer, storage, display, and/or format conversion of medical device data – called Medical Device Data Systems (MDDSs)- from class III (high risk) to Class I (low risk).  

In addition, the draft guidance points out that the FDA previously clarified “that when standalone software is used to analyze medical device data, it has traditionally been regulated as an accessory to a medical device or as medical device software.” Further, the FDA holds that mobile medical apps, like traditional medical devices, can pose potential risks to public health. Moreover, medical apps may pose additional or different risks due to the unique characteristics of the platform.  

Definitions

  1. MOBILE PLATFORM—The guidance defines “mobile platforms” as commercial off the shelf (COTS) computing platforms, with or without wireless connectivity, that are handheld in nature.
  1. MOBILE APPLICATION (mobile app)—The guidance defines “mobile application” or “mobile app” as a software application that can be executed (run) on a mobile platform, or a web based software application that is tailored to a mobile platform but is executed on a server.
  1. MOBILE MEDICAL APPLICATION (mobile medical app)—The guidance defines “mobile medical app” as a mobile app that meets the definition of “device” in section 201(h) of the Federal Food, Drug and Cosmetic Act (FD&C); and either: is used as an accessory to a regulated medi cal device or transforms a mobile platform into a regulated device.

According to the guidance, “The intended use of a mobile app determines whether it meets the definition of a ‘device.’” The guidance continues, “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 representative. When the intended use of the 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. In general, if a mobile app is intended for use in performing a medical device function it is a medical device regardless of the platform on which it is run.”

  1. REGULATED MEDICAL DEVICE—A regulated medical device is defined as a product that meets the definition of device in section 201(h) of the FD&C Act and that has been classified by the FDA, or otherwise approved or cleared by the FDA review of a premarket application or other submission for the device.
  1. MOBILE MEDICAL APP MANUFACTURER—According to the guidance, “a ‘mobile medical app manufacturers’ is defined as any person or entity that manufactures mobile medical apps in accordance with 21 CFR Parts 803, 806 and 807. This term does not include entities that exclusively distribute mobile medical apps, without engaging in manufacturing functions.”  

The guidance points out that, a mobile platform manufacturer that commercially markets a mobile platform with an intended use (as defined in 21 CFR 801.4) of, or to be used with a device is considered a device manufacturer under 21 CFR 803, 806, and 807. In contrast, a mobile platform manufacturer that solely distributes or markets its platform with no device intended use is considered a component manufacturer and is exempt from quality systems, registration and listing requirements as described in those regulations. In other words, the fact that a mobile platform could be used to run a mobile medical app identified by this guidance does not mean that the mobile platform manufacturer is considered a medical device manufacturer. For example, if it is possible to run mobile medical apps on BrandNamePhone, but BrandNamePhone is not marketed by BrandNameCompany with a medical device intended use, then BrandNameCompany would not be a medical device manufacturer.  

Scope

The draft guidance document outlines FDA’s desire to apply its regulatory requirements to a subset of mobile apps. This bulletin described those apps in its regulated products section, and includes only those apps that meet the statutory definition of a device; and either:

  1. Are used as an accessory to a regulated medical device; or
  2. Transform a mobile platform into a regulated medical device

The guidance is limited only to mobile medical apps. The following examples represent mobile apps that the FDA does NOT consider to be mobile medical apps for purpose of this guidance:

  1. Mobile apps that are electronic copies of medical textbooks, teaching aids, reference materials, or are solely used to provide clinicians with training or reinforce training previously received. An example would be “The electronic Physician’s Desk Reference” (PDR).
  2. Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific identifiable health condition. Examples of these apps include dietary tracking logs, appointment reminders, dietary suggestions based on a calorie counter, posture suggestions, exercise suggestions, or similar decision tools that generally relate to healthy lifestyle and wellness.
  3. Mobile apps that focus on or only automate general office operations. This would include billing and coding functions.
  4. Mobile apps that are generic aids that assist users, but are not commercially marketed for a specific medical indication. 5. Mobile apps that perform the functionality of an electronic health record system or personal health record system.

Regulatory Approach For Mobile Medical Apps

  • The FDA intends to apply regulatory oversight only to certain types of mobile apps.
  • According to the draft guidance document, the FDA will focus only on a subset of mobile apps “that either has traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device.”
  • The guidance continues, “Although some mobile apps that do not meet the definition of a mobile medical app may meet the FD&C Act’s definition of a device, FDA intends to exercise enforcement discretion toward those mobile apps. The FDA intends to monitor the performance of other mobile apps that are outside this guidance and determine whether additional or different actions are necessary to protect the public health. A manufacturer may, however, at its discretion, elect to register and list, and to seek approval or clearance for these mobile apps with the FDA.”
  • For the subset of mobile medical apps that fall under the regulatory umbrella, manufacturers must meet the requirements associated with the applicable device classification. The guidance dictates that, “A mobile medical app, like other devices, may be classified as class I (general controls), class II (special controls or performance standards), or class III (premarket approval).”
  • The guidance is clear, “FDA is seeking comment on how it should approach mobile medical apps that are accessories to other medical devices so safety and effectiveness can be reasonably assured. Mobile medical devices that are intended to be used as accessories to a regulated medical device may do so for purposes of (a) displaying, analyzing, storing, or transmitting patient-specific medical device data, or (b) controlling the operation, function, or energy source of the medical device.”
  • The guidance concludes with an unambiguous statement: “Finally, if the mobile medical app adds medical device functionality to a mobile platform, the mobile medical app manufacturer MUST (emphasis added) meet the classification requirements applicable to that functionality.”

Mobile Medical Apps for which FDA Will Apply Regulatory Oversight

The guidance specifically outlines mobile apps it will consider for regulatory oversight. They include:

  1. “Mobile apps that are an extension of one or more medical device(s) by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data. Examples of displays of patient-specific medical device data include remote display of data from bedside monitors, display of previously stored EEG waveforms, and display of medical images directly from a Picture Archiving and Communications System (PACS) server, or similar display functions that meet the definition of an MDDS. Examples of mobile apps that control medical devices include apps that provide the ability to control inflation and deflation of a blood pressure cuff through a mobile platform and mobile apps that control the delivery of insulin on an insulin pump by transmitting control signals to the pumps from the mobile platform.”
  2. “Mobile apps that transform the mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. An example includes a mobile app that uses a mobile platform for medical device functions, such as attachment of a transducer to a mobile platform to function as a stethoscope.”
  3. “Mobile apps that allow the user to input patient-specific information and – using formulae or processing algorithms –output a patient specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions.”

Conclusion

The draft guidance concludes with information relating to requirements for mobile medical device manufacturers subject to regulatory oversight. Basically this section just describes applicable device classification regulation. This article is only intended to give an overview of the topic. For more detail and depth, see the FDA draft guidance document “Mobile Medical Applications.”2 The FDA is seeking input on this guidance document. Comments may be submitted online or in writing by October 19, 2011.