OIRA Conclusion of EO 12866 Regulatory Review

RIN: 0910-ZC55         View EO 12866 Meetings	Received Date: 09/09/2025
Title: Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Agency/Subagency: HHS / FDA	Stage: Notice
Concluded Action: Consistent with Change	Concluded Date: 12/15/2025
Legal Deadline: None	Economically Significant: No
Publication Date:	Unfunded Mandates: No
Major: No	Related To Homeland Security: No
Regulatory Flexibility Analysis Required: No	Small Entities Affected:
Federalism Implications: No	Affordable Care Act [Pub. L. 111-148 & 111-152]: No
International Impacts: No	Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No
Pandemic Response: No