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Policy Updates New Guidance

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Womble Bond Dickinson

Bureau of Land Management Updates Its Mitigation Policies

Womble Bond Dickinson on

Late last month, the Bureau of Land Management (“BLM”) issued Instruction Memorandum 2021-046 to reinstate both BLM Manual Section (MS-1794) and BLM Handbook (H-1794-1), which restore previously rescinded BLM policies on...more

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