资讯

JD Supra4 个月
FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions
On January 6, 2025, FDA released a draft guidance entitled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. In accordance ...
JD Supra4 个月
New guidance on AI-enabled device software functions clarifies information FDA expects in ...
On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing ...