When the Model Is the Vendor: What Happens to Compliance When You Don’t Own the Weights
The FDA cleared its first LLM-based device in December 2025 and the public record does not say which model it runs. Every regulated-software regime assumes you can describe, pin and reproduce what you shipped — a manufacturer building on someone else's foundation model can do none of the three reliably.
- On September 3, 2026
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