Last week, The U.S. Food and Drug Administration (the "FDA") issued long-awaited final guidance for the mobile medical applications ("Apps") industry and FDA staff (the "Guidance"). The Guidance notes that it contains guidance only and that the recommendations included in the Guidance do not establish legally enforceable responsibilities; however, App developers should act quickly to determine if their Apps in the market, or in the development pipeline, will face scrutiny and/or regulation. Some Apps easily meet the definition of a "medical device" under Section 201(h) of the Federal Food, Drug and Cosmetic Act ("FD&C Act") as they could pose a risk to patient safety if the Apps do not function as intended, while other Apps potentially fall within the definition of a "medical device" but pose lower risks and therefore should be subject to a lower level of regulation. The Guidance seeks to provide clarity and predictability of the FDA's current approach to exercising its enforcement discretion.
The critical measuring point for whether or not an App will be subjected to regulation lies in the intended use of the App. Specifically, the Guidance notes that the FDA will focus its oversight only on Apps that (i) intend to be used as an accessory to a regulated medical device or (ii) intend to transform a mobile platform into a regulated device. The Guidance also clarifies that "In general, if a mobile app is intended for use in performing a medical function (i.e., for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease) it is a medical device, regardless of the platform on which it is run."
The Guidance was careful to note that the FDA's regulatory oversight and enforcement was limited to the functionality of Apps and would not focus on the sale or use of consumer smartphones or tablets being transformed into medical devices by the Apps, an important carve-out for mobile device companies that sell the hardware on which they operate. Furthermore, the FDA intends to regulate only manufacturers of Apps, and not those who exclusively distribute Apps without engaging in manufacturing functions. The Guidance characterizes App manufacturers as "anyone who initiates specifications, designs, labels, or creates a software system or application for a regulated medical device in whole or from multiple software components." Thus, the mobile application market places will not face regulatory scrutiny simply by offering Apps for sale to consumers.
The Guidance offers detailed appendices of three different categories of Apps to aid companies in determining whether the intended use of their App will cause it to face FDA regulation.
The first category includes those Apps that the FDA does not consider to meet the definition of medical devices, and as such, will go unregulated by the FDA. These Apps include those meant to serve as medical references for both physicians and patients (such as a medical dictionary or encyclopedia that defines medical terms for the user), educational Apps for medical training, or Apps meant to facilitate medical office functions, like scheduling doctor shifts or tracking insurance claim data.
The second category are Apps that meet the definition of medical device, but for which the FDA intends to exercise its discretion to refrain from regulation, because the Apps pose low risk to patients. This category of Apps includes those intended for use in facilitating patient care (e.g., Apps that coach patients with simple prompts that reminds the patient to exercise).
The third category are those Apps that the FDA considers medical devices and that the FDA believes pose a significant risk of patient harm if they were to function improperly. These types of Apps oftentimes enable a mobile device to operate as a regulated medical device (e.g., use of sensors to measure certain bodily functions), or enable a device to operate as a controller for a regulated medical device App (e.g., an App that acts as a wireless remote for an X-Ray machine). The FDA intends that Apps falling into this category will be subject to the same risk-based approach used by the agency to assess and regulate traditional medical devices. The FDA refers to this third category of Apps as "Mobile Medical Apps." As with any regulated medical device, Mobile Medical App manufacturers and developers must meet requirements associated with the applicable device classification. The Guidance notes: "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)."
As noted above, the intended use of any App is critical to determining if it will become subject to FDA scrutiny and regulation. Developers that promote their Apps for use in performing the function of a medical device, such as the diagnosis of medical conditions, a cure, mitigation or treatment, should be prepared for such Apps to be regulated by the FDA. It is critical that manufacturers and developers engage regulatory experts before going to market to avoid delays in market timing, or worse, enforcement actions after an App has already been promoted and sold.
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.
