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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On 3 April 2023, FDA issued a draft guidance for industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device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 Through the draft guidance, FDA intends to provide a least burdensome approach to support iterative improvements to machine learning-enabled device software functions or ML-DSFs through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The draft guidance follows FDA’s April 2019 publication of a Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as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.


Xin Tao is a member of Baker McKenzie's North America Steering Committee for Healthcare & Life Sciences, and currently heads our US Food and Drug Law Practice. A former research biochemist, Xin brings a deep understanding of the complex scientific issues that relate to the US FDA's legal and regulatory requirements, enabling him to help clients with all phases of product development, manufacturing, and marketing. As the science and technology continues to evolve, Xin supports our clients to constantly innovate and push the boundaries of what's possible in the world of life science. Xin is a frequent speaker and writer on US FDA legal developments related to emerging technology, and he has been selected to serve on the 2023 Law360 Life Sciences Editorial Advisory Board.


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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