This article is a brief overview of the draft mHealth guidance issued on Tuesday by the FDA (the "Draft Guidance"), and the first in a series presenting and exploring the implications of this long-awaited guidance. In future editions, we will closely review FDA's initial thoughts and plans for the regulation of mobile medical applications and then continue to explore specific open issues raised by the regulation, effects on different stakeholders, and hot issues that bubble to the surface as the mHealth community engages.

McGuireWoods’ FDA Practice is currently crafting comments on behalf of aligned stakeholders in the mHealth industry. If you would like to have your voice heard through these efforts, or are otherwise interested in FDA regulatory support, please contact the authors of this article.

FDA Issues Long-Awaited mHealth Draft Guidance, Comments Due October 17

On Tuesday, FDA issued its Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications. The Draft Guidance provides a brief background on the mHealth concept, defines what is and what is not a mobile medical app for FDA purposes, and sets out the FDA's regulatory approach for such apps.

Background

As technology has evolved in both the medical and communications arenas, innovators have begun to develop mobile apps of increasing complexity to leverage the portability mobile platforms can offer. This has culminated in an explosion of software applications for mobile platforms that are user friendly, computationally powerful, and readily available to assist both individuals in wellness management and healthcare providers in patient care.

FDA had attempted in the past to issue policies on software, but had not been able to come up with a comprehensive software guidance in this ever-changing industry. With a path for mobile health technology charted in the marketplace at this time, FDA has issued this Draft Guidance in an effort to clarify and outline its current thinking on the matter.

Scope

FDA has determined to apply its regulatory oversight only to certain types of mobile applications or “mobile apps,” which FDA defines generally as software applications that can be run on a mobile platform, or a web-based software application that is tailored to a mobile platform but is executed on a server.

FDA has decided to focus regulation on only the subset of mobile apps that either have traditionally been considered medical devices or affect the performance or functionality of a currently regulated medical device. FDA names this subset "mobile medical apps" and believes that it poses the same or similar potential risk to the public health as currently regulated devices if they fail to function as intended.

A mobile medical app is a mobile app that meets the definition of "device” under the Food, Drug and Cosmetic Act and either:

  • is used as an accessory to a regulated medical device; or
  • transforms a mobile platform into a regulated medical device.

The following are NOT considered to be mobile medical apps:

  • Mobile apps that are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received.
  • 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.
  • Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication.
  • Mobile apps that perform the functionality of an electronic health record system or personal health record system.

Furthermore, a regulated mobile medical app manufacturer is any person or entity that manufactures mobile medical apps in accordance with 21 CFR Parts 803, 806, and 807. A mobile medical app manufacturer:

  • Does not include distributors like "iTunes store" and "BlackBerry App World."
  • Includes anyone who initiates specifications, designs, labels, or creates a software system or application in whole or from multiple software components or provides functionality thereof.

Regulatory Framework

For the subset of mobile medical apps that are subject to regulatory oversight, manufacturers must meet the requirements associated with the applicable device classification. If the mobile medical app, on its own, falls within a medical device classification, its manufacturer is subject to the requirements associated with that classification. A mobile medical app, like other devices, may be classified as class I (general controls), class II (special controls in addition to general controls), or class III (premarket approval).

Finally, if the mobile medical app adds medical device functionality to a mobile platform, the mobile medical app manufacturer must meet the classification requirements applicable to that functionality.

The full text of the Guidance can be found here.