# Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions:  Guidance for Industry and Food and Drug Administration Staff – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/cybersecurity-in-medical-devices-quality-management-system-considerations-and-content-of-premarket-submissions-guidance-for-industry-and-food-and-drug-administration-staff/c4b51224-1f4e-47a1-beaf-b041cce046fd

> FDA guidance document: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions:  Guidance for Industry and Food and Drug Administration Staff. Issue date: February 03, 2026. Get complete insights and analysis.

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## Details

- Title: Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions:  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: 2026-02-03
- Last Changed: 2026-02-03
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-1158">FDA-2021-D-1158</a>

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