# Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency:  Guidance for Industry and Food and Drug Administration Staff – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/validation-of-certain-in-vitro-diagnostic-devices-for-emerging-pathogens-during-a-section-564-declared-emergency-guidance-for-industry-and-food-and-drug-administration-staff/09c36b30-818f-4b05-8c6b-971e6b5a0a0a

> FDA guidance document: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency:  Guidance for Industry and Food and Drug Administration Staff. Issue date: November 10, 2026. Get complete insights and analysis.

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## Details

- Title: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency:  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: 2026-11-10
- Last Changed: 2026-11-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-2707">FDA-2024-D-2707</a>

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