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# Test Emergency Policies Under Sec. 564 Guide
- URL: https://www.fdaweb.com/test-emergency-policies-under-sec-564-guide/
- Published: 2024-05-06T12:00:00.000Z
- Updated: 2026-09-14T14:30:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156917

*Federal Register* notice: FDA is making available a draft guidance entitled “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” The document describes the factors FDA intends to assess when deciding to issue an enforcement policy on test manufacturers’ unapproved tests and unapproved uses of approved tests during a declared emergency. Under section 564, HHS may determine that there is a public health emergency or significant potential for a public health emergency, thus permitting FDA to issue an emergency use authorization before the emergency occurs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-05-06/pdf/2024-08933.pdf?ref=fdaweb.com).