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# Guide on Public Health Emergency IVDs
- URL: https://www.fdaweb.com/guide-on-public-health-emergency-ivds/
- Published: 2024-05-01T12:00:00.000Z
- Updated: 2026-09-14T14:29:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156895

*Federal Register* notice: FDA is making available a draft guidance entitled “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564.” In certain public health emergencies, there may be need for certain in vitro diagnostic devices (IVDs) to be available for immediate response purposes. The guidance describes the agency’s enforcement policy for laboratory manufacturers offering certain unauthorized IVDs for immediate response to emergencies in the absence of a declaration applicable to IVDs under the Federal Food, Drug, and Cosmetic Act. To view the notice, click [here](https://public-inspection.federalregister.gov/2024-08934.pdf?ref=fdaweb.com).