The Food and Drug Administration (FDA) FDA first issued draft guidance "Policy for the Regulation of Computer Products" in 1989. The guidance was never finalized and instead retracted in 2005. It wasn't till February 15, 2011 that the FDA issued a regulation regarding computer and software that could transfer, store, display, or convert medical device data. The FDA later issued specific guidance for MHealth applications (apps) on September 25, 2013 which has been replaced by updated guidance on February 9, 2015. From the guidance we understand that the FDA doesn't want to regulate all MHealth applications since 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."
MHealth Apps defined
The FDA guidance describes regulated apps as "meets the definition of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and either 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 intent of an app considered when determining the applicability of regulation as a MHealth app. The MHealth app is designed or marketed to with the ability to perform medical device functions.
Regulated MHealth Apps
- 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.
- 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. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
- Become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.
MHealth Apps Potentially Exempt from FDA Regulation
- Provide or facilitate supplemental clinical care, by coaching or prompting, to help patients manage their health in their daily environment.
- Provide patients with simple tools to organize and track their health information.
- Provide easy access to information related to patients’ health conditions or treatments (beyond providing an electronic “copy” of a medical reference).
- Are specifically marketed to help patients document, show, or communicate to providers potential medical conditions.
- Perform simple calculations routinely used in clinical practice.
- Enable individuals to interact with PHR systems or EHR systems.
- Meet the definition of Medical Device Data Systems. 
MHealth Apps Exempt from FDA Regulation
- Intended to provide access to electronic “copies” (e.g., e-books, audio books) of medical textbooks or other reference materials with generic text search capabilities.
- intended for health care providers to use as educational tools for medical training or to reinforce training previously received.
- Intended for general patient education and facilitate patient access to commonly used reference information.
- Automating general office operations in a health care setting and are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
- Generic aids or general purpose products. These apps are not considered devices because they are not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
Implications for MHealth App developers
Developers of regulated MHealth apps should identify the current classification covering their mobile medical app. Prior to marketing MHealth apps, developers need to prepare and submit premarket materials described on the FDA website to the FDA based on the device type. However, the FDA Quality System is recommended for all application developers regardless of status to address issues including software-related failures resulting from a failure to validate software prior to routine maintenance . The FDA has provided guidance regarding the Quality System online at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070897.htm. Going forward the application of the 2015 guidance on MHealth apps and the 2003 guidance on Quality Systems will have an important impact on the quality and benefit from the developing market. In 2014 it was estimated that there were 40,000 apps with health, fitness, and medical purposes. The same source describes a compound annual growth rate of 47.6% over a six year period making the proper development of both regulated and unregulated apps important for the benefit of the population.
- IT Law Wiki Page on 1989 draft policy
- 2015 Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff - issued February 9, 2015
- Section 201 of FD&C Act
- FDA regulated device registration and listing website
- Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
- QRCode Press article on Mobile health apps
Submitted by (Eric J. Vinson)