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- FDA Wants to Credential AI Like a Doctor. The Infrastructure Doesn't Exist.
FDA's competency-based framework for generative AI medical devices closes for public comment on October 19 — but the governance infrastructure to actually run it doesn't exist yet, and most manufacturers haven't mapped their products to the two-axis risk framework.
- The EU AI Act High-Risk Deferral Is a Trap, Not a Reprieve
The EU AI Act Digital Omnibus deferred the Annex III high-risk deadline to December 2027 — but that's exactly one conformity assessment cycle, and Article 50 transparency obligations are already live. Banks that filed this as a win are already behind.
- The EU AI Act Omnibus Saved Your Credit Model. It Didn't Save Your LLM Stack.
The EU AI Act Omnibus moved the credit scoring deadline to December 2027 — but GPAI enforcement and Article 50 transparency go live August 2, and banks using LLMs in production workflows are exposed right now.