Find here all our blog posts tagged with: AI-enabled devices.

Abstract image of countless glowing data strands funneling into a narrow beam of light, symbolizing regulatory oversight straining against a surge of AI-driven medical data.

The Governance Gap Behind FDA's AI Device Surge

FDA's AI-enabled device authorizations are scaling faster than lifecycle governance infrastructure, and the same gap is now stalling AI drug discovery approvals.

A single small gear straining to drive a much larger network of interlocked gears, symbolizing regulatory capacity strain.

When the Regulator's Capacity Becomes Your Risk

FDA's shrinking resourcing and the MDUFA VI negotiations mean AI device sponsors can no longer treat PCCP approval as the end of verification.

A clinical monitor showing an AI-annotated lung scan beside a regulatory approval document on a desk.

The Benchmark Gap Inside FDA's AI Change Control Plans

FDA's Predetermined Change Control Plan guidance lets AI devices update without new submissions, but no validated benchmarking standard tells manufacturers where drift becomes risk.