Life Sciences Is Merging Two EU AI Act Obligations Into One
EU AI Act transparency rules for content marking and interaction disclosure are distinct obligations, and life sciences compliance teams keep treating them as one.
Find here all our blog posts tagged with: generative AI.
The Readiness Gap Behind FDA's 1,000 AI Devices
FDA's large base of authorized AI-enabled devices masks a readiness gap that generative and agentic systems will expose immediately.
The Real Gap Isn't Evidence. It's Framework Fit.
AI medical device clearances are outpacing the regulatory architecture meant to govern them, and hospitals are deploying generative AI ahead of any classification at all.
FDA's GenAI Framework Is Still a Draft of a Draft. That's the Opportunity.
FDA's two-axis risk framework for generative AI medical devices is not policy yet, and the October 19 comment window is the cheapest chance to shape it before it hardens.
The Comment Window That Will Define GenAI Medical Devices
FDA's open docket on generative AI medical devices is the narrow window life sciences leaders have to shape binding rules before they harden.
What FDA's Tempo Pilot Actually Asks Compliance Leaders to Decide
FDA's reported Tempo pilot lets generative AI devices reach patients ahead of authorization, and the public record on how is thinner than the headline suggests.
The Blind Spot Beneath FDA's Generative AI Test
FDA's two-axis approach to generative AI devices is a familiar SaMD extension, but existing inspection data suggest most manufacturers can't yet clear the bar it sets.
FDA's Three-Part Test for Agentic Devices
FDA's generative AI discussion paper outlines a safety, proficiency, and generalizability framework that will shape validation evidence long before formal guidance arrives.
The Generative AI Gap in FDA's Device Playbook
FDA has cleared over 1,000 AI-enabled devices, but generative AI features still lack a defined regulatory pathway, forcing sponsors to choose their architecture carefully.
The Governance Gap Belongs to the Deployer, Not the Regulator
Hospitals and pharma functions adopting generative AI now carry governance obligations that device and drug frameworks were never built to cover.
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.
