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# Guide on Enforcement Discretion for Emergency-Use IVDs
- URL: https://www.fdaweb.com/guide-on-enforcement-discretion-for-emergency-use-ivds/
- Published: 2025-09-22T12:00:00.000Z
- Updated: 2026-09-14T15:22:15.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159905

FDA has released a [final guidance](https://www.fda.gov/media/178123/download?ref=fdaweb.com) outlining how the agency will decide when to temporarily allow use of unapproved diagnostic tests during a declared public health emergency. The guidance, *Consideration of Enforcement Policies for In Vitro Diagnostic (IVD) Tests During a Section 564 Declared Emergency*, explains the factors FDA will consider in determining when to issue, and when to end, an enforcement policy permitting certain unapproved IVD tests on the market. The policies could apply to both entirely unapproved tests and unapproved uses of already approved tests, the agency says.

FDA says the document is meant to provide a more predictable framework for balancing urgent testing needs against potential risks during crises such as outbreaks or bioterrorism events. In past emergencies, including Covid-19 and Mpox, the agency relied on enforcement discretion to expand testing access when demand exceeded the supply of FDA-authorized or approved tests.

The new policy follows a 2022 Government Accountability Office (GAO) report, which urged FDA to clarify under what conditions it would exercise enforcement discretion for unauthorized tests in future emergencies, the agency says. The GAO recommended that FDA outline when such a policy would begin and end, ensuring that it is applied consistently and transparently.

According to the guidance, FDA intends to initiate an enforcement policy only when the benefits outweigh the risks — for example, when there is an urgent need to test large numbers of people and available authorized tests are insufficient. Factors such as the reliability of the test technology and the experience of the manufacturer will also be considered.

The agency says it will periodically reassess the factors during an emergency. Enforcement discretion will be withdrawn once authorized or approved tests become widely available or when testing demand declines.