FDA Publishes Draft Guidance and Announces Workshop on Robotic Medical Devices

Date

October 8, 2026

Category

US Regulations

Description

The FDA published the draft guidance “Robotically-Assisted Surgical Devices – Premarket Submissions” on September 25, 2026. Comments may be submitted until November 24, 2026 under Docket ID FDA-2026-N-9505.

The guidance provides recommendations on non-clinical testing, clinical data, and labeling for certain robotically-assisted surgical devices (RASDs). The FDA defines RASDs as teleoperated, software-controlled systems that assist qualified practitioners in positioning and controlling surgical instruments during open, minimally invasive, or endoluminal procedures.

The document addresses the specific performance and safety characteristics of robotic surgical platforms, including teleoperation capabilities, system controls, kinematics and dynamics, visualization, reliability, software, cybersecurity, wireless technology, human factors, training, electrical safety, and clinical evidence.

In parallel, the FDA will host the hybrid public workshop “Evaluating Benefit-Risk in Robotic Medical Devices with Autonomous or Remote Teleoperation Capabilities” on December 2 and 3, 2026. The workshop will be available virtually and in person at the FDA’s White Oak Campus in Silver Spring, Maryland.

The event will bring together manufacturers, regulatory professionals, healthcare providers, patients, and other stakeholders. Discussions will focus on terminology, technical considerations, and the probable benefits and risks of robotic medical devices with autonomous or remote teleoperation capabilities. The feedback may also inform future FDA policy in this evolving area.

Participation is free, but registration is required. In-person registration closes on November 23, 2026, or earlier if capacity is reached. Virtual registration will remain open after that date.