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GUIDANCE DOCUMENT

Robotically-Assisted Surgical Devices - Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff September 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2026-N-9505

Docket Number:
FDA-2026-N-9505
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides recommendations on non-clinical testing, clinical data, and labeling to support premarket submissions for certain robotically-assisted surgical devices (RASDs). RASDs are teleoperated, software-controlled systems that integrate robotic technologies and subassemblies that are designed to assist qualified practitioners in precisely positioning and controlling one or more surgical instruments to safely and effectively perform open, minimally invasive, or endoluminal procedures. The recommendations reflect FDA’s current thinking for these devices and are intended to promote consistency and facilitate efficient review of RASD submissions.

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