Lexology January 21, 2025
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of AI on intellectual property, licensing, contracts, regulatory policy, enforcement, privacy, and venture markets in life sciences.
On January 6, 2025, FDA released a draft guidance entitled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. In accordance with FDA’s total product life cycle (TPLC) approach to the oversight of medical devices, the draft guidance outlines marketing submission content recommendations for devices that include at least one artificial intelligence (AI)-enabled device software function, as well...
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