OIRA Conclusion of EO 12866 Regulatory Review


RIN: 0910-ZB06         View EO 12866 Meetings Received Date: 03/11/2022 
Title: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff 
Agency/Subagency: HHS / FDA   Stage: Notice 
Concluded Action: Consistent with Change  Concluded Date: 04/05/2022 
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: 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