The US Food and Drug Administration (FDA) has finalized a long-anticipated guidance on using predetermined change control plans (PCCPs) in submissions for medical devices with artificial intelligence ...
The US Food and Drug Administration (FDA) has issued a draft guidance detailing what modifications the agency considers appropriate for pre-determined change control plans (PCCPs), and what ...
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device ...
In the past 18 months, the FDA has outlined clear guidelines for designing, documenting, updating, and monitoring AI-powered ...
The U.S. Food and Drug Administration (FDA) is seeking comments on methods of assessing the real-world performance of AI-enabled medical devices, including generative AI. Prior FDA draft guidance has ...
Finally, the terminology shift worth flagging is QMSR replacing the “Design History File” with “Design and Development File”, ...
The International Medical Device Regulators Forum (IMDRF) has issued a draft guidance for predetermined change control plans for software as a medical device. The problem for advocates of regulatory ...
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