Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more
The US Food and Drug Administration (FDA or the Agency) recently issued its draft guidance titled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more
5/2/2023
/ Artificial Intelligence ,
Comment Period ,
Draft Guidance ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Manufacturers ,
Marketing Authorization Application ,
Medical Devices ,
Pre-Market Notification ,
Software