Coverage of FDA’s AI/ML Medical Devices Workshop - Part 1: The History of FDA Software Regulation
Summary
Prior to the meeting, we will explore the history of FDA’s regulation of software-enabled medical devices and stand-alone software and the agency’s more recent progress with digital health policies. Software devices, on the other hand, may be modified (e.g., to add functionality or additional types of data inputs and outputs) relatively easily and individual but significant modifications may be quickly developed and released. • Multiple functionalities – Many hardware devices have a single intended use that can be defined in a few sentences or less (e.g., a blood pressure cuff, a specimen collection vial, or a stethoscope). FDA has spent a significant amount of time and effort developing guidelines and policies relating to device cybersecurity and has released multiple guidance documents on the subject. Next week, we will give a quick tour of the agency’s recent actions to create policies and processes that better accommodate advanced software technologies as medical devices, as well as their developers.