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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-9505

FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices

💬 Comments close in 57 days (Nov 24)

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  1. Proposed / opened

    FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices

Briefs in this proceeding

High FDA 💬 Comments close in 57 days (Nov 24)

FDA Issues Draft Guidance on Premarket Submissions for Robotically-Assisted Surgical Devices

The FDA seeks input on evidence requirements for RASDs, including AI integration, cybersecurity, and clinical performance, to shape future clearance pathways. The FDA has released draft guidance outlining recommendations for premarket submissions of robotically-assisted surgical devices (RASDs),...

Sources

Health and Human Services Department, Food and Drug Administration · Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability · Sep 25