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. 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 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. 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 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. 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 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. Furthermore, the FDA intends to regulate only manufacturers of Apps, and not those who exclusively distribute Apps without engaging in manufacturing functions.
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. 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.” 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 critical measuring point for whether or not an App will be subjected to regulation lies in the intended use of the App. The Guidance seeks to provide clarity and predictability of the FDA’s current approach to exercising its enforcement discretion.
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 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. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”).