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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
On December 3, 2024, the US Food and Drug Administration (FDA) published final guidance titled, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
On August 16, 2022, US Congress enacted Reese’s Law, which aims to protect children from ingestion hazards associated with certain lithium batteries found in consumer electronics. The law stems from the death of 18-month-old...more
The US Copyright Office (CO) issued a notice, seeking comments on copyright law and policy issues raised by artificial intelligence (AI) systems. Artificial Intelligence and Copyright, 88 Fed. Reg. 59942 (Aug. 30, 2023)....more
The Cybersecurity Administration of China ("CAC") and six other agencies jointly promulgated Interim Measures for the Administration of Generative Artificial Intelligence Services ("Generative AI Measures" or "Rules"), that...more
The interim administrative measures, which are the first comprehensive AI regulations in the People’s Republic of China (PRC or China), apply only to using generative AI technology to provide services to the public within the...more