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Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance for Industry and Food and Drug Administration Staff May 2024

Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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

This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2023-D-5365

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 FDA is issuing this draft guidance to describe the factors we intend to assess when deciding to issue an enforcement policy regarding test manufacturers’ offering of certain unapproved tests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).

 
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