Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.

Tags

health IT, Notice, Health and Human Services Department, Food and Drug Administration

Related exam domains

CISA 3: Information Systems Acquisition, Development and Implementation; CISA 4: Information Systems Operations and Business Resilience

Source record id

2026-19704

First seen by InfoSec Signals

10/9/2026

Source: Federal Register API, Office of the Federal Register, National Archives and Records Administration · about this source · more from it

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