Devices

AI/ML Software Marketing Submission Guidance

FDA has published a draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, to provide “a forward-thinking approach to promote the development of safe and effective medical devices that use machine learning (ML) models trained by ML algorithms.” The document says FDA recognizes that the development of machine learning-device software functions (ML-DSF) is an iterative process.

“This draft guidance proposes a least burdensome approach to support iterative improvement through modifications to an ML-DSF while continuing to provide a reasonable assurance of device safety and effectiveness. As such, this draft guidance demonstrates FDA’s broader commitment to developing innovative approaches to the regulation of device software functions as a whole.”

Specifically, the guidance has recommendations on the information to be included in a predetermined change control plan (PCCP) provided in a marketing submission for an ML-DSF. The draft recommends that a PCCP describe planned ML-DSF modifications; the associated methodologies to develop, implement, and validate those modifications; and an assessment of the impact of those modifications. The PCCP is reviewed as part of a marketing submission to ensure the continued safety and effectiveness of the device without necessitating additional marketing submissions for implementing each modification described in the PCCP, the agency says.

The guidance contains Introduction, Background, Scope, Definitions, Policy for Predetermined Change Control Plan, Description of Modifications, Modification Protocol, Impact Assessment, and two 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