Many of us, myself included, can’t leave home without our smart phone or tablet computer safely tucked into our purse or briefcase. With the tap of the screen, we can access mobile applications (affectionately referred to as “apps”) that provide us with useful information, games to help us pass the time, and various helpful, and not so helpful, tools. Mobile apps are even available to patients to help them manage an existing disease, such as diabetes, and to healthcare practitioners to assist in the diagnosis of disease and/or the operation of other devices. On July 21, 2011, FDA issued its Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications, placing the life sciences industry on notice of FDA’s “current thinking” regarding its intention to regulate certain types of mobile applications as medical devices or accessories. According to this Draft Guidance, FDA intends to regulate a subset of mobile apps, referred to and defined as “mobile medical apps,” that meet the statutory definition of a device and are either (1) used as an accessory to a regulated device or (2) transform a mobile platform into a regulated medical device. In its definition, FDA further defines a “medical mobile app” by stating that “[w]hen the intended use of a mobile app is for the diagnosis of disease or other condition, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”
While FDA plans to only apply its regulatory authority to this subset of devices, life science companies that offer mobile apps must now determine whether their app falls within the scope of a regulated medical mobile app. FDA’s Draft Guidance provides an exemplary lists of mobile apps that FDA will and will not regulate as medical mobile apps. FDA will not regulate mobile apps that:
- Are electronic copies of medical textbooks, teaching aids, or reference materials;
- Are solely used to log, record, track, evaluate or make decisions or suggestions related to general health or wellness, as opposed to an app that allows for input of patient-specific information and produces a general diagnosis;
- Automates general office operations;
- Provides generic tools that are not marketed for specific medical uses, such as a magnifying glass, recording audio, note taking, etc.; or
- Serves the function of an electronic health record system or personal health system.
Conversely, FDA will regulate mobile apps as medical devices if the app:
- Connects to a medical device to control the device or displaying, storing, analyzing, or transmitting patient-specific data (i.e., control the delivery of insulin on an insulin pump by transmitting control signals to the pump or inflate a blood pressure cuff);
- Transforms a mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities that are similar to currently regulated medical devices (i.e., attachment of a blood glucose strip reader to a mobile platform to function as a glucose meter or attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store, and display ECG signal); or
- Allows the user to input patient-specific information and, with the assistance of formulae or processing algorithms, produces a patient-specific result, diagnosis, or treatment recommendation.
If a mobile device falls within the scope of FDA’s mobile medical app, the manufacturer of the mobile medical app must comply with the applicable regulations for the classification of the medical device, which includes General Controls (Establishment Registration, Medical Device Listing, Quality System Regulation, Labeling Requirements, Medical Device Reporting, Premarket Notification, Reporting Corrections and Removal, and Investigational Device Exemption), Special Controls, and/or Premarket Approval.
FDA is seeking public comments on this guidance document until October 19, 2011. The public can submit comments online at http://www.regulations.gov/ identifying the docket number listed in the notice of availability published in the Federal Register (Docket No. FDA-2011-D-0530) or in writing to:
Division of Documents Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
FDA is also hosting a Public Workshop on Mobile Medical Applications Draft Guidance on September 12-13 to provide a forum for discussion with FDA of the Draft Guidance and to encourage public comment from interested stakeholders. For more information regarding registration for the workshop, please click here.
FDA’s intended regulation of mobile apps as medical devices is founded on the mitigation of potential risks to public health. Going forward, life science companies that thought they were providing useful tools to patients and practitioners will now be faced with the burden of deciding if their mobile apps are regulated. It is likely that many pharmaceutical companies may discover they are now manufacturers or distributors of medical devices and subject to a new landscape of medical device regulations. Life science companies should seize the opportunity to engage FDA in a dialogue now, during the formation of the draft guidance, rather than later.