Ingestible medical devices offer novel diagnostic, monitoring, and treatment capabilities. This article explores the regulatory landscape of ingestible devices in the US, highlighting the US Food and Drug Administration (FDA) classifications, clearance, and approval processes. It discusses preclinical and clinical data considerations, postmarket requirements, and challenges in bringing these devices to the market. The article includes examples of ingestible devices cleared and approved in the last decade, their timelines, and the potential of these emerging technologies to revolutionize patient care…
