# Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/enforcement-policy-for-certain-in-vitro-diagnostic-devices-for-immediate-public-health-response-in-the-absence-of-a-declaration-under-section-564-draft-guidance-for-laboratory-manufacturers-and-food-and-drug-administration-staff/966637d7-cac0-46c1-9ebb-bf25c55c8774

> FDA guidance document: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff. Issue date: May 06, 2024. Get complete insights and analysis.

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## Details

- Title: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564: Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff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: 2024-05-06
- Comment Close Date: 2024-07-05
- Last Changed: 2024-04-29
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-0083">FDA-2024-D-0083</a>

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