Food and Drug Administration Issues Final Guidance on Mobile Medical Applications

摘要

On September 27, 2013, the Food and Drug Administration (FDA) announced the availability of guidance entitled "Mobile Medical Applications."The FDA issued this guidance to inform manufacturers, distributors, and other entities about how it intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or "mobile apps").At this time, the FDA intends to apply regulatory requirements to only a small subset of mobile apps, referred to in this guidance as mobile medical applications (mobile medical apps).Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this guidance document to clarify the subset of mobile apps to which the FDA intends to apply its authority. Many mobile apps are not medical devices (meaning such mobile apps do not meet the definition of a device under section 201 (h) of the Federal Food, Drug, and Cosmetic Act [FD&C Act]), 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, the FDA intends to exercise enforcement discretion over these devices (meaning it will not enforce requirements under the FD&C Act). Most mobile apps on the market at this time fit into these 2 categories.