On July 19, 2011, FDA issued a draft guidance on mobile medical applications in which FDA clarifies the types of mobile applications to which it intends to apply its regulatory authority and how it intends to apply its regulatory authority to those mobile applications. In the draft guidance, FDA indicated that, at this time, it intends to regulate only to a subset of mobile apps that it defines as “mobile medical applications,” or “mobile medical apps.” FDA defines a “mobile medical app” as a mobile app that meets the definition of “device” under the Food, Drug, and Cosmetic Act (FDCA) and either (1) is used as an accessory to a regulated medical device; or (2) transforms a mobile platform into a regulated medical device. (A “device” is . . . “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man . . . or . . . intended to affect the structure or any function of the body of man or other animals . . . and which does not achieve its primary intended purposes through chemical action within or on the body of man . . . and which is not dependent upon being metabolized for the achievement of its primary intended purposes. “)
Under the draft guidance, manufacturers of mobile medical apps must the regulatory requirements associated with the applicable device classification. If the app adds medical device functionality to a mobile platform (such as a smart phone), FDA indicates that the app would be required to meet the regulatory requirements associated with that functionality. Noting that the traditional approach of regulating devices that are accessories to another medical device -- requiring the accessory to meet the requirements associated with that other medical device – may not be well-suited for mobile medical apps, FDA requests comment on how it should approach the regulation of apps that are accessories to other devices. FDA intends to exercise its enforcement discretion with respect to other mobile apps that meet the definition of “device,” but are not mobile medical apps. Among the mobile apps that FDA does not consider mobile medical apps are apps that perform the functionality of electronic health record (EHR) or personal health record (PHR) systems.
The notice of availability of the draft guidance will be published in the Federal Register on Friday, July 21, 2011, and comments are requested within 90 days of publication to ensure consideration in the preparation of the final guidance.
The draft guidance is available on FDA’s website: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/U CM263366.pdf.
The notice of availability of the draft guidance is available on the Federal Register’s public display website: http://ofr.gov/OFRUpload/OFRData/2011-18537_PI.pdf.