FDA issues draft guidance for robotic surgical devices

The FDA has released draft guidance outlining expectations for nonclinical testing, clinical evidence, and labeling for robotically assisted surgical devices. This guidance applies to software-controlled systems used in open, minimally invasive, or endoluminal procedures. The agency has scheduled a workshop for December 2–3 to examine the technical, safety, and regulatory challenges specifically related to autonomous and remotely operated robotic systems.

In a related development, Medevise Consulting will host a workshop titled “Robotics in Ophthalmology: What it takes to create a game changing technology” in New Orleans on October 8, 2026. Held during the American Academy of Ophthalmology annual meeting, the event will feature experts discussing regulatory hurdles, reimbursement landscapes, and the potential for robotic technology to surpass current standards of care in eye surgery.