Policy For Device Software Functions & Mobile Medical Applications: Guidance For Industry & Food & Drug Administration Staff

On September 27, 2019, the United States Food & Drug Administration (FDA) released this guidance for industry and FDA staff regarding device software functions and mobile medical applications policy. This guidance document informs 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”) or on general-purpose computing platforms. The document differentiates between a mobile platform, mobile application, medical mobile application, regulated medical device, and mobile medical application manufacturer. The document also contains a scope and regulatory approaches and requirements . . .