Pending EO 12866 Regulatory Review

RIN: 0910-ZC07	Received Date: 08/26/2024
Title: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff
Agency/Subagency: HHS / FDA	Stage: Notice
Legal Deadline: None	Section 3(f)(1) Significant: No
International Impacts: Yes	Affordable Care Act [Pub. L. 111-148 & 111-152]: No
Pandemic Response: No	Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]: No