# Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency:  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/consideration-of-enforcement-policies-for-in-vitro-diagnostic-tests-during-a-section-564-declared-emergency-guidance-for-industry-and-food-and-drug-administration-staff/21848893-1a28-4ffe-a5eb-e86a79546ffb

> FDA guidance document: Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 23, 2025. Get complete insights and analysis.

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## Details

- Title: Consideration of Enforcement Policies for In Vitro Diagnostic Tests 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: 2025-09-23
- Last Changed: 2025-09-22
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-5365">FDA-2023-D-5365</a>

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