The FDA issued new guidance in February 2015 (Draft Guidance) to inform stakeholders about the subset of mobile medical applications to which it intends to apply its regulatory authority. The FDA recognizes that most mobile medical apps pose no risk to patients and cannot be considered to be medical devices. Apps that won’t be regulated include apps such as medical training videos, medical dictionaries, and gaming apps used to train healthcare professionals in certain skills, such as advanced cardiopulmonary resuscitation. Additionally, apps used to educate patients, determine billing codes, or collect data for insurance claims won’t be regulated. Appendix A of the guidance document spells out the kinds of mobile apps that are not medical devices.
Some mobile medical apps may meet the definition of a device, but the FDA plans to exercise what it terms enforcement discretion. This means that because these apps pose a very low risk of patient harm, the agency won’t regulate them. Examples of mobile apps in this group are ones designed to help people quit smoking, motivate people to exercise, or track medication usage. Appendix B of the guidance document provides an extensive list of other examples.
The FDA, however, does plan to regulate mobile apps that meet the definition of a device and that could pose a risk to patient safety should they not function as intended. The FDA identifies 3 categories of mobile medical apps that it will regulate:
- Those “that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or for use in active patient monitoring or analyzing medical device data.”
- Those “that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.”
- Those “that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations.”
Appendix C of the guidance document lists examples of these apps that will be the focus of the FDA’s oversight.
The takeaway message is that regulatory requirements may apply to certain mobile medical apps, depending on their intended use. Developers need to know when a mobile medical app meets the definition of a medical device and follow the appropriate regulatory process before bringing the app to market.