Episode Details

The US FDA released a new draft guidance on September 24, 2026, outlining its expectations for premarket submissions of Robotically-Assisted Surgical Devices (RASDs).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 Key Questions: - What is the scope of the FDA's new draft guidance on Robotically-Assisted Surgical Devices?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 FDA now recommend for RASD premarket submissions? - Under what circumstances will clinical data be required for a new or modified RASD? - How have labeling and training requirements changed for robotic surgery systems? - What are the key human factors considerations the FDA emphasizes for these devices? - How should manufacturers adjust their 510(k), De Novo, or PMA strategies in light of this guidance? - What practical steps should my regulatory team take today to prepare? Sources: - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/robotically-assisted-surgical-devices-premarket-submissions - https://www.fda.gov/news-events/cdrh-new-news-and-updates/september-24-2026-robotic-medical-devices-public-workshop-evaluating-benefit-risk-robotic-medical How Pure Global can help: Navigating new FDA guidance for complex devices like Robotically-Assisted Surgical Devices requires deep regulatory expertise. Pure Global helps MedTech and IVD companies streamline global market access with end-to-end regulatory consulting. Our experts can develop efficient regulatory strategies for your 510(k), De Novo, or PMA submission, prepare technical dossiers using advanced AI, and act as your local representative. We combine global reach with local expertise to get your products to market faster. For support with your US market access strategy, contact us at info@pureglobal.com or visit https://pureglobal.com. Explore our free AI-powered regulatory tools and device database at https://pureglobal.ai.