The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Orthopaedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices.” The purpose of the workshop is to discuss the development of Orthopaedic SMART Devices. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with Orthopaedic SMART Devices. Public input and feedback gained through this workshop may aid in the efficient development of innovative, safe and effective, Orthopaedic SMART Devices, for better patient care.