Enforcement Policy for Certain IVDs for Immediate Response

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All written comments should be identified with this document's docket number: FDA-2024-D-0083

Guidance Issuing Office

Center for Devices and Radiological Health

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, exposures to harmful chemicals, and public health emergencies. FDA is issuing this draft guidance to describe the Agency's enforcement policy for certain laboratory manufacturers offering certain unauthorized in vitro diagnostic devices for immediate response to chemical, biological, radiological, or nuclear agents in the absence of a declaration applicable to IVDs under section 564 of the Federal Food, Drug, and Cosmetic Act. This policy set forth in the draft guidance is intended to help ensure the government's coordinated and effective public health response during an emergent situation.