FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reform

The U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The draft aims to clarify how developers can meet regulatory requirements and invites public comment before finalization.

The guidance addresses key topics such as risk assessment, data integrity, and post‑market monitoring, signaling the FDA’s intent to provide a clearer pathway for AI‑enabled technologies.

In Europe, industry groups have voiced concerns that Germany’s current drug pricing framework is overly restrictive. They argue that the pricing rules limit the ability of pharmaceutical companies to invest in new therapies and could hinder innovation.

Stakeholders are urging German policymakers to consider reforms that balance cost containment with incentives for research and development, emphasizing the broader impact on the European pharma market.