Latest US Food and Drug Administration news, funding rounds and robotics & AI coverage. 1 article tracked by The Robotics Media.
The US Food and Drug Administration (FDA) is a federal executive branch agency within the Department of Health and Human Services. Its Center for Devices and Radiological Health (CDRH) regulates all medical devices marketed in the United States, including surgical robots and AI-enabled medical software. In September 2026 the FDA issued its first comprehensive draft guidance for premarket submission of robotically-assisted surgical devices (RASDs).