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United States: FDA Issues Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning

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In brief

On 3 April 2023, FDA issued a draft guidance for industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, for manufacturers whose medical devices use machine learning (ML) technologies to improve patient care. Through the draft guidance, FDA intends to provide a least burdensome approach to support iterative improvements to machine learning-enabled device software functions or ML-DSFs through modifications, while continuing to provide a reasonable assurance that the device is safe and effective. In essence, manufacturers can proactively seek FDA’s concurrence with the intended modifications to the applicable devices without additional marketing submissions for each modification in the future.

The draft guidance follows FDA’s April 2019 publication of a Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD), which delineates FDA’s general framework for a potential approach to premarket review for AI/ML driven software modifications.

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Adam Aft helps global companies navigate the complex issues regarding intellectual property, data, and technology in M&A and technology transactions. He is the lead of the Firm's North America Technology Transactions group and co-leads the group globally. Adam also served as a law clerk to the Honorable Leslie H. Southwick of the US Court of Appeals for the Fifth Circuit and the Honorable Theresa L. Springmann of the US District Court for the Northern District of Indiana.

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Xin's practice focuses on novel food and drug applications that require FDA review and FDA Current Good Manufacturing Practices (cGMP) compliance. Xin has extensive experience advising food technology companies and investors on developing and marketing innovative products including cell-cultured meat, protein derived from microbial fermentation and bioengineering. Xin has also represented pharmaceutical companies during many FDA cGMP on-site inspections around the globe involving all aspects of cGMP regulations including sterile manufacturing and data integrity. A former research biochemist, Xin brings a deep understanding of the complex scientific issues that relate to the FDA's legal and regulatory requirements, enabling him to help clients with all phases of product development, manufacturing, and marketing. Leveraging his scientific background, he has also worked extensively on FDA enforcement actions and consumer class action litigations involving environmental contaminants in foods such as heavy metals, PFAS, and California’s Proposition 65- listed chemicals

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Genevieve M. Razick is an associate in the Litigation and Government Enforcement Practice Group in the Washington, DC office. Genevieve practices in the area of US Food and Drug Administration and healthcare regulatory and compliance law.

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