With over 350,000 apps available through the leading online retailer of mobile Apps, it’s not surprising that, like everyone else, FDA wanted a piece of the action. On Tuesday, FDA announced the availability of a Draft Guidance document outlining how it intends to regulate “mobile medical apps” - a new term of art for the telehealth industry. The Draft Guidance is the latest in a growing list of statements and rules, including the recent announcement of its Medical Device Data Systems (MDDS) Final Rule , that describe FDA’s regulatory framework for software, hardware, and IT solutions that perform or facilitate health or medical functions. Although FDA does not have an overarching regulatory policy regarding computer software, it has determined that in some circumstances, software solutions are medical devices. In the case of mobile apps, some of those, too, will require FDA scrutiny.
Congress has defined a medical device as, among other things, any instrument, apparatus, implement, or machine that is intended:
- for use in the diagnosis of disease or other conditions; or
- for use in the cure, mitigation, treatment, or prevention of disease; or
- to affect the structure or any function of the body.
A mobile app is regulated as a mobile medical app when meets the definition of a medical device and either:
- is used as an accessory to a regulated medical device; or
- transforms a mobile platform (such as a smart phone or tablet computer) into a regulated medical device.
Before you start to think that just about everything on your new smart phone is now an FDA-regulated product, FDA has carved out certain apps that it does not consider to be within the scope of its Draft Guidance. FDA included mobile versions of educational texts or reference manuals, such as the Physician’s Desk Reference, among the examples of apps that it does not intend to regulate as mobile medical apps. Some of the fitness buffs among our subscribers may be interested to know that apps that log or track fitness goals, provide general health or fitness recommendations, or monitor and count our calories are also not considered mobile medical apps. The same can be said for apps that help with electronic medical records or personal health record systems, and apps that automate general office operations such as scheduling appointments, billing, and the dreaded insurance transactions.
Examples of apps that are regulated as medical mobile apps include:
- apps that display patient-specific data, such as MRI scans or X-rays, for physicians’ review;
- apps that work in concert with an insulin pump to monitor and control the delivery of the proper dose of insulin;
- apps that utilize smart phones to acquire medical data and draw conclusions from that data; and
- apps that analyze patient-specific data to assist in the care of a patient or to recommend a specific treatment action.
In determining both whether a solution is a mobile medical app and the degree of regulatory oversight that will apply to devices that are mobile medical apps, FDA will consider how the app is being used and marketed. For devices that meet the definition of a mobile medical app, the degree of oversight will depending on issues such as the level of integration or connection between the app and other medical devices, the device-to-device connections, and, of course, the labeling, marketing and promotional materials for the product or solution. FDA intends to require general controls (such as registration, listing, manufacturing quality systems, and adverse event reporting) for all mobile medical apps. If, however, the app performs functions that are similar to currently regulated medical devices or functions that are critical to patient diagnosis or treatment decisions, FDA may require greater oversight, including premarket review in the form of a 510(k) or premarket application (PMA), along with other “special controls” that FDA deems necessary to assure the safety and effectiveness of a particular device.
FDA is still deciding how it will handle apps that are intended to function with multiple types of medical devices or integrate information from several different sources or types of medical devices. The agency is soliciting comments from the public on this and other issues to clarify its approach to regulating mobile apps. Stay iTuned for further details.