How to Measure Performance for AI-Enabled Medical Devices? FDA Seeks Public Input
On September 30, 2025, the U.S. Food and Drug Administration (FDA ) posted a Request for Public Comment regarding how to measure the performance of medical devices enabled with artificial intelligence (AI). The...
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay...
Keeping Up With AI: FDA Issues Guidance on Predetermined Change Control Plans (PCCPs) for Artificial Intelligence (AI)-Enabled Devices
On August 18, 2025, the Food and Drug Administration (FDA) issued guidance (Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions) to provide recommendations...
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