FDA Robotic Surgery Guidance: Key Changes for Premarket Submissions

Podcast: Medical Device Global Market Access · Pure Global

Opublikowano: 2026-09-29

The US FDA released a new draft guidance on September 24, 2026, outlining its expectations for premarket submissions of Robotically-Assisted Surgical Devices (RASDs). This episode breaks down the key recommendations covering non-clinical testing, clinical data requirements, and specific labeling considerations. We also highlight the critical November 24, 2026, deadline for submitting comments and provide practical steps for manufacturers to align their regulatory strategies with the FDA's current thinking. Key Questions: - What is the scope of the FDA's new draft guidance on Robotically-Assisted Surgical Devices? - When is the deadline to submit comments on this new guidance? - What specific non-clinical testing does the...