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GUIDANCE DOCUMENT

Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance for Industry and Food and Drug Administration Staff May 2024

Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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.

Docket Number:
FDA-2023-D-5365
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 and other threats. FDA is issuing this draft guidance to describe the factors we intend to assess when deciding to issue an enforcement policy regarding test manufacturers’ offering of certain unapproved tests during a future declared emergency under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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-2023-D-5365.

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