Devices

AI-DSF Change Control Plan Guidance

FDA has published a guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions, recommending that such a plan describe the planned artificial intelligence-enabled device software function (AI-DSF) modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the modifications’ impact. The document says FDA reviews the predetermined change control plan as part of a marketing submission for a medical device to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the control plan.

FDA says it recognizes that the development of AI-enabled devices is an iterative process. “This guidance describes an approach that would often be the least burdensome for manufacturers to support iterative improvements through modifications to an AI-DSF while continuing to provide a reasonable assurance of device safety and effectiveness,” the guidance says.

The document contains an Introduction, Background, Scope, Definitions, Policy for Predetermined Control Change Plans, Description of Modifications, Modification Protocol, Impact Assessment, and Appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome