The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...

The FDA published its first draft guidance on the use of AI in the development of drugs and biological products ...

An AI system developed to predict a patient's response to immunotherapy could help "democratize" access to the pricey drugs ...

The FDA is releasing the first-ever guidance on how the pharmaceutical industry can use AI. Nick Kostos and Femi Abebefe ...

The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, highlighting the importance of providing the regulator with detailed information ...

The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

This is a KFF Health News story. Preparing cancer patients for difficult decisions is an oncologist's job. At the University ...

The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.