1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency Guidance for Industry and Food and Drug Administration Staff September 2025

Download the Final Guidance Document Read the Federal Register Notice
Final
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 final guidance to describe the factors we intend to assess when deciding to issue an enforcement policy regarding test manufacturers’ offering of certain unapproved in vitro diagnostic tests during a future relevant 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.

Back to Top