Pending EO 12866 Regulatory Review
RIN: 0910-ZC17 | Received Date: 10/29/2024 |
Title: Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
Agency/Subagency: HHS / FDA | Stage: Notice |
Legal Deadline: None | Section 3(f)(1) 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 |