The FDA has issued its long awaited Final Guidance on Mobile Medical Applications, which has been in draft form since July 21, 2011. Although the FDA's guidance does not establish legally enforceable responsibilities, guidance describes the Agency's current thinking on a topic and should generally be viewed only as recommendations. The guidance does not address the approach for software that performs patient-specific analysis to aid or support clinical decision-making.
The purpose of the guidance document is to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms, known as mobile applications or "mobile apps." Many mobile apps are not medical devices and the FDA does not regulate them. Some mobile apps may meet the definition of a medical device but because they pose a lower risk to the public, FDA intends to exercise enforcement discretion over these devices.
The FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient's safety if the mobile app were to not function as intended. The FDA refers to these mobile apps as mobile medical apps.
When stand-alone software is used to analyze medical device data, it has been traditionally regulated as an accessory to a medical device or as medical device software. The FDA is focused on certain mobile medical apps which can pose potential risks to public health.
The Guidance defines a "mobile medical app" as a mobile app that meets the FDA's definition of a device and is intended to be used as an accessory to a regulated medical device, or to transform a mobile platform into a regulated medical device.
The intended use of a mobile app determines whether it meets the definition of a "device."
Under the Guidance, the FDA would not regulate the sale or general/conventional consumer use of smartphones or tablets. The FDA's oversight applies to mobile apps performing medical device functions, such as when a mobile medical app transforms a mobile platform into a medical device.
The FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate to prevent patient and user harm.
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).
The FDA provides some illustration as to the types of mobile apps that it considers to be mobile medical apps, subject to regulatory oversight:
- Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.
- Mobile apps that transform the mobile platform into regulated medical devices by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.
- Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations.
The FDA will exercise enforcement discretion for mobile apps that:
- Help patients self-manage their disease or conditions without providing specific treatment or treatment suggestions.
- Provide patients with simple tools to organize and track their health information.
- Provide easy access to information related to patients' health conditions or treatments.
- Help patients document, show, or communicate potential medical conditions to healthcare providers.
- Automate simple tasks for healthcare providers.
- Enable patients or providers to interact with Personal Health Records or Electronic Health Record systems.
These are exciting times in mHealth, and the attorneys in Schwabe's Healthcare Information & Technology group stand ready to answer any questions you might have about the new Final FDA Guidance.