What FDA Cleared in an LLM-Enabled SaMD, and What It Didn't
FDA cleared UpDoc (K253281) as a Class II insulin-dose calculator, substantially equivalent to a 2019 predicate, with no clinical data and a change-control plan that preserves deterministic dosing. The public framing is "agentic clinical AI." A regulatory reading of the gap, and what it means for anyone building LLM-enabled SaMD.
EU Released Its Draft High-Risk AI Guidelines. Here's What Life Sciences Companies Actually Need to Read.
On May 19, 2026, the European Commission published the long-anticipated draft Commission guidelines on the classification of high-risk AI systems under Article 6 of Regulation (EU) 2024/1689. A clause-level walkthrough of the two-prong safety component test, the Annex III narrow-task filter, the conformity assessment module clarification, and the Digital Omnibus timeline reality. What medical device, SaMD, IVDR, and life sciences AI manufacturers should do before the consultation closes June 23.
Claude for Life Sciences Just Made LLM Compliance Urgent. Here's the Framework.
Anthropic's life sciences and healthcare push, from the January 11 Claude for Healthcare launch through the May 14 Gates Foundation partnership, has accelerated LLM adoption in pharma, medical device, biotech, clinical research, and provider operations. The compliance posture has not kept pace. The framework for scoping 21 CFR Part 11, FDA CSA, EU AI Act, IEC 62304, ICH E6(R3), HIPAA, GAMP 5, and Agent Skills governance against specific LLM use cases.
FDA Just Held Its First QMSR Town Hall. Here's What the Enforcement Data Already Tells Us.
132 Form 483 observations across 52 inspections. 89.4% cite ISO 13485:2016 clauses directly. 50% of inspected firms received risk management observations. The first comprehensive analysis of post-QMSR enforcement data from FDA's public databases, combined with intelligence from the April 1, 2026 Town Hall.