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Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Comment period open: closes in 38 days (Nov 24, 2026). Comment on Regulations.gov →
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Submit a comment · Add to calendar (.ics)
Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.
- Document type
- Notice
- Federal Register document number
- 2026-19704
- Published
- Sep 25, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-N-9505
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by November 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- Medical devices
Source: Federal Register API, document 2026-19704. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.