The U.S. Food and Drug Administration, or FDA, regulates, as a medical device, software that is intended or labeled for healthcare purposes. The FDA divides the regulation of software into the following three categories:
Software which meets the definition of a medical device under the Food, Drug, and Cosmetic Act. Such software is referred to as software as a medical device (SaMD); Software that is integral to a medical device, also known as software in a medical device (SiMD); and Software used in the manufacture of a medical device. This article focuses on the FDA’s Digital Health Software Precertification program, or Pre-Cert program, and its evolving, forward-looking regulation of SaMD; and on an ongoing Pre-Cert Pilot program that is an important step along the path to implementing the Pre-Cert program.
