2026 PCCP Is Settled. The Benchmarks Underneath It Are Not. FDA's change control pathway for AI-enabled devices is mature, but the benchmarking standards sponsors need to use it well are still unresolved.
2026 Generative AI Isn't Breaking Device Rules. It's Avoiding Them. FDA's generative AI vacuum in clinical SaMD is pushing vendor activity toward drug discovery applications that sit outside device regulation entirely.
