# 2026-19704: FDA's Robot Surgery Approval Cheat Sheet Drops for Makers

2026-19704, Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-09-25, effective Submit either electronic or written comments on the draft guidance by November 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.; PRIA reads it as touching household money (as of 2026-10-02).

- Canonical: https://policyrisk.com/federal-register/2026-19704
- As of: 2026-10-02
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-19704
- Title: Robotically-Assisted Surgical Devices-Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 60967
- Published: 2026-09-25
- Effective: Submit either electronic or written comments on the draft guidance by November 24, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Comments close: 2026-11-24
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-10-02

## In one line

FDA's Robot Surgery Approval Cheat Sheet Drops for Makers

## Summary

The FDA just dropped a draft guide for companies making robot-assisted surgical devices, showing how to get their products approved before selling. If you’re in the biz, now’s the time to check it out and send your feedback by November 24, 2026. This guide aims to make the approval process clearer and smoother, potentially saving time and money down the road.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance titled "Robotically-Assisted Surgical Devices--Premarket Submissions." This draft guidance provides draft recommendations for premarket submissions for robotically- assisted surgical devices (RASDs). This draft guidance is not final nor is it for implementation at this time.

## Effects PRIA read

- Draft recommendations for RASD premarket tests: benefit, medium. If you make robotically-assisted surgical devices (RASDs), the FDA released a draft guidance that gives recommendations for non-clinical and clinical testing and for what to include in premarket submissions. The document says these recommendations are intended to promote consistency and facilitate…
- Opportunity to comment by Nov 24, 2026: benefit, low. Stakeholders can submit electronic or written comments on the draft guidance; comments must be submitted by November 24, 2026 for consideration before FDA begins work on the final guidance. Comments may be submitted at https://www.regulations.gov (Docket No. FDA-2026-N-9505) or as written/paper sub…
- Draft guidance is nonbinding and optional: benefit, low. The FDA states the draft guidance is not final or for implementation and, when finalized, will represent the Agency's current thinking. You may use an alternative approach if it satisfies applicable statutes and regulations.
- No new paperwork collections under PRA: benefit, low. The guidance states it contains no new collection of information under the Paperwork Reduction Act and instead refers to previously OMB-approved FDA collections, including control numbers 0910-0120, 0910-0231, 0910-0078, 0910-0844, 0910-0756, 0910-0485, 0910-0073, 0910-0449, 0910-0130, and 0910-011…

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## Sources
- [2026-19704 on federalregister.gov](https://www.federalregister.gov/documents/2026/09/25/2026-19704/robotically-assisted-surgical-devices-premarket-submissions-draft-guidance-for-industry-and-food-and)
- [2026-19704 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-09-25/pdf/2026-19704.pdf)

## Related
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- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-19704 (as of 2026-10-02).