# Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices:   Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/d18b3a42-ad8b-4987-8955-ea08f4372049

> FDA guidance document: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices:   Guidance for Industry and Food and Drug Administration Staff. Issue date: December 18, 2025. Get complete insights and analysis.

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## Details

- Title: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices:   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: 2025-12-18
- Last Changed: 2026-02-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-4395">FDA-2023-D-4395</a>

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