Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.
Abstract as published in the Federal Register.
The comment window is still open until November 24, 2026. The comment window is open. Check the document itself for what comments are being solicited on and what weight they carry. Submit comments through the Federal Register document below.
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