Pending EO 12866 Regulatory Review

RIN: 0910-ZD68	Received Date: 09/10/2026
Title: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
Agency/Subagency: HHS / FDA	Stage: Notice
Legal Deadline: None	Economically Significant: No
International Impacts: No	Affordable Care Act [Pub. L. 111-148 & 111-152]: No
Pandemic Response: Yes	Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No