On December 4, 2024, FDA finalized its guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions” (the “2024 Final...more
On September 27, 2023, FDA finalized its guidance entitled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions” (the “2023 Final Guidance”). The Final Guidance replaces...more
10/11/2023
/ Artificial Intelligence ,
Cybersecurity ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Homeland Security Cybersecurity & Infrastructure Security Agency (CISA) ,
Machine Learning ,
Medical Devices ,
NTIA ,
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Premarket Approval Applications ,
Risk Management ,
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