By Bruce A. MacFarlane, PhD
The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smartphone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of healthcare professionals via mobile medical applications (“apps”) resident on these devices. These apps raise unique challenges for regulation by the Food and Drug Administration (FDA).
On July 21, 2011, FDA responded to the industry’s growing interest in commercializing mobile medical apps by issuing a draft guidance document. On September 25, 2013 FDA issued its final guidance: Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff.
The guidance defines mobile apps that constitute medical devices. Next, FDA indicates the kinds of medical mobile apps for which the Agency will exercise “enforcement discretion,” meaning it will not enforce the applicable requirements of the Food, Drug, and Cosmetics Act. It then outlines regulatory requirements and closes with appendices focusing on examples to illustrate the principles of the guidance.