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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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564 Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff May 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Docket Number:
FDA-2024-D-0083
Issued by:
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 FDA is issuing this draft guidance to describe the Agency’s enforcement policy for certain laboratory manufacturers offering certain unauthorized in vitro diagnostic devices for immediate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 This policy set forth in the draft guidance is intended to help ensure the government’s coordinated and effective public health response during an emergent situation.

 
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