Federal Register #2026-19704

FDA Draft Guidance for Robotically-Assisted Surgical Devices Premarket Submissions

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released a draft guidance for robotically-assisted surgical devices (RASDs). - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Services Requested: - No products, part numbers, or purchase quantities are requested - The guidance focuses on robotically-assisted surgical devices (RASDs), which are teleoperated, software-controlled systems for surgical procedures - Unique or Notable Requirements: - The guidance outlines recommendations for premarket submissions, including non-clinical and clinical testing requirements - Stakeholders are invited to submit comments electronically or in writing - The notice is not a procurement solicitation but a request for public comment on the draft guidance - Technical Information: - RASDs are designed to assist practitioners in performing surgical procedures with precision - The guidance aims to promote consistency and facilitate efficient review of submissions

Description

The Food and Drug Administration (FDA) is announcing the availability of draft guidance providing recommendations for premarket submissions for robotically-assisted surgical devices (RASDs). These devices are teleoperated, software-controlled systems designed to assist qualified practitioners in performing surgical procedures with precision. The draft guidance aims to promote consistency and facilitate efficient review of premarket submissions. Comments on the draft guidance are requested by November 24, 2026, and the guidance is not final nor for implementation at this time.

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