JD Supra

Code Red: The FDA’s Artificial Intelligence/Machine Learning Action Plan Poses Potential Risks for Medical Device Makers

"The gathering and transmitting of personal data represents a major cyber threat to medical devices and must be extremely carefully thought through." Q: The FDA’s stance on a regulatory framework for ...
techtarget

FDA Releases Action Plan for AI, Machine Learning Medical Software

The FDA has released its first artificial intelligence and machine learning action plan, a multi-step approach designed to advance the agency’s management of advanced medical software. The Artificial ...
JD Supra

FDA Issues Artificial Intelligence/Machine Learning Action Plan

On January 12, 2021, the US Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The Action Plan ...
Homeland Security Today

FDA Releases Artificial Intelligence/Machine Learning Action Plan

The U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a ...