JD Supra14 天
FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how ...
JD Supra24 天
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” ...