OIRA Conclusion of EO 12866 Regulatory Review


RIN: 0910-AH99         View EO 12866 Meetings Received Date: 12/06/2023 
Title: Medical Devices; Quality System Regulation Amendments 
Agency/Subagency: HHS / FDA   Stage: Final Rule 
Concluded Action: Consistent without Change  Concluded Date: 01/05/2024 
Legal Deadline: None  Economically Significant: No 
Publication Date:   Unfunded Mandates: No 
Major: Yes  Related To Homeland Security: No 
Regulatory Flexibility Analysis Required: Undetermined  Small Entities Affected: No 
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