22 - FDA regulation of anesthesia and critical care medical devices

Abstract

The focus of this chapter is the United States medical device regulatory landscape as related to the regulation of anesthesiology and critical care devices. Fundamental concepts such as, medical device definition, classification process, and various premarket regulatory pathways are discussed. The chapter then focuses on the currently evolving regulatory requirements related to digital health technologies, such as the regulatory framework for Software as a Medical Device, Clinical Decision Support Software, automation, and artificial intelligence in anesthesia and critical care medical devices. Through extensive review of FDA guidance documents and recent regulatory frameworks related to digital health medical devices, the chapter provides a comprehensive overview of FDA regulation applied to innovative anesthesia and critical care medical devices.