Mobile communication devices, particularly smartphone and applications, have already changed how we handle many aspects of our lives, such as personal finance, shopping, travel and entertainment. They are also radically changing the way we think and make decisions about our healthcare.
Manufacturers of regulated Mobile Medical Applications (MMA) bear the onus of having to prove their device’s safety and efficacy to regulatory agencies. These manufacturers are held to regulatory standards, and any proclamations that they make about their MMA must meet regulatory labeling requirements. While barriers to market entry are high, the rewards of taking an MMA to market are higher if the manufacturer embraces the MMA strategy in a deliberate and systematic fashion, all the while paying close attention to critical success factors surrounding reimbursement, regulatory and clinical areas, and proving improved clinical outcomes for patients.
This article introduces the MMA topic, background and current framework of MMA and examines the life cycle of an MMA.
What are Mobile Medical Applications?
FDA’s website¹ defines mobile apps and MMAs as:
“…software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software. Mobile medical apps are medical devices that are mobile apps, meet the definition² of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.”
FDA’s MMA guidance³ document explains that FDA does not intend to regulate all types of MMAs, but only a subset of them. To help us understand the types of MMA that FDA does intend to regulate, we can categorize MMAs as one of the following.
MMAs that FDA will not regulate – Typically a mobile app that is used in healthcare or lifestyle management does not fit the definition4 of a medical device, in that it does not diagnose, cure, mitigate, treat or prevent a disease in man or animal. FDA does not intend to regulate such mobile apps. Examples include electronic medical textbooks or an electronic listing of diseases and conditions, educational tools for training healthcare providers or patients, healthcare office workflow automation tools, etc.
MMAs for which FDA intends to exercise enforcement discretion – Sometimes, a mobile app may fit the definition of a medical device, but pose a low risk to the public health. FDA intends to exercise enforcement discretion for these. Examples include devices intended to help patients with certain diagnosed psychiatric conditions to maintain behavioral coping skills, motivational mobile apps, GPS-based apps alerting patients to certain environmental conditions, apps that use gaming technology to motivate patients to do physical therapy exercises and apps that allow patients to send an alert or emergency notification to first responders.
MMAs that FDA will regulate – These meet the definition of a medical device and pose risk to public safety if they do not function as intended by the manufacturer. Examples include those that transform a mobile platform, such as an iPhone, into a regulated medical device with an existing medical device product code, apps that connect to an existing device type for purposes of controlling its operation, function or energy source, and apps that display, transfer, store, or convert patient-specific medical device data from a connected device. (Product codes, developed by the Center for Devices and Radiological Health, are unique and associated with a particular type of devices and code of federal regulations. For example, LFR, CGA, NBW and CFR are a few of the product codes associated with glucose test systems under 21 CFR § 862.1345.)
The Lifecycle of a Mobile Medical Application
Simplistically, the lifecycle of an MMA follows that of a medical device. Life begins when the MMA is conceptualized. At this stage, the manufacturer has some type of quality system in place. Regulatory and reimbursement strategies are formulated. A clinical strategy is developed, if the MMA requires clinical data to provide regulators with assurance of safety and efficacy of the device. As part of MMA risk assessment, hazard analysis, usability/human factors and software development lifecycle considerations can be implemented in parallel with strategy development. At the verification and validation stage, each software input requirement specification is verified and validated with a ”pass” result. Product freeze is then declared. At this point, if the MMA requires a clinical study, an Institutional Review Board submission follows and MMA study is initiated upon approval.5 Upon study completion, data points are gathered and summarized into a regulatory report for submission. Upon a successful submission, clearance is obtained. The manufacturer begins marketing and distribution, as well as ideation discussions for the next generation MMA.