# Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/robotically-assisted-surgical-devices-premarket-submissions-draft-guidance-for-industry-and-food-and-drug-administration-staff/1f41f2a7-7066-4cdf-8d44-208bb7bf9cdd

> FDA guidance document: Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff. Issue date: September 25, 2026. Get complete insights and analysis.

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## Details

- Title: Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2026-09-25
- Comment Close Date: 2026-11-24
- Last Changed: 2026-09-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-N-9505">FDA-2026-N-9505</a>

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