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Product safetyFDAUnited StatesImports

Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

25 September 2026

In plain English

FDA announced a draft guidance titled Robotically-Assisted Surgical Devices Premarket Submissions, offering draft recommendations for premarket submissions for RASDs, not yet final or for implementation.

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Topic
Product safety
Regulator
FDA
Published
25 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.

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