The Food and Drug Administration (FDA) is issuing this draft guidance document to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”).
Given the rapid expansion and broad applicability of mobile apps, the FDA is issuing this draft guidance document to clarify the types of mobile apps to which the FDA intends to apply its authority. At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or “mobile medical apps.”
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.
Source: U.S. Food and Drug Administration