FDA's Final Guidance Provides Practical Approach for AI-Enabled Devices Implementing Post-Market Modifications
By EsqSocial Corporation 27/12/24
As a streamlined method for obtaining U.S. Food and Drug Administration ("FDA") authorization of post-market functionality, FDA issued final guidance recommending the information to include in a Predetermined Change Control Plan in marketing submissions for intended modifications of artificial intelligence ("AI")-enabled devices....
By: Jones Day