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McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

McDermott+

FDA Issues Final Guidance on Predetermined Change Control Plans for AI-Enabled Devices

McDermott+ on

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

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

Ropes & Gray LLP on

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

ArentFox Schiff

Top 10 Legal Issues for 2024 For the Consumer Products Industry

ArentFox Schiff on

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

McDermott Will & Emery

Copyright Office Seeks Comments on Artificial Intelligence

McDermott Will & Emery on

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

Davis Wright Tremaine LLP

China's Cyberspace Administration Releases "Interim" Rules Regulating the Use of Generative AI

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

Pillsbury Winthrop Shaw Pittman LLP

China Finalizes Its First Administrative Measures Governing Generative AI

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

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