Design Controls Weren't Built for Models That Change
FDA is piloting exceptions rather than rewriting design controls for GenAI devices, leaving compliance leaders to build the continuous verification the rule doesn't require.
Find here all our blog posts tagged with: SaMD.
The Change-Control Gap Between MDR and the AI Act
Predetermined change control plans reveal the specific reconciliation gap between MDR/IVDR certification and EU AI Act obligations for adaptive medical algorithms.
Clearance Was Never the Finish Line
FDA's predetermined change control pathway shifts the real compliance burden from initial authorization to lifecycle governance of AI models after they ship.
The Real AI Device Risk Is Where FDA Doesn't Look Closely
Most AI-enabled devices clear FDA through the least rigorous pathway or avoid device classification entirely, leaving agentic AI's failure modes unexamined.
The Doctor Test for AI Devices
FDA's move toward clinician-style, ongoing assessment of AI-enabled devices reshapes what counts as durable evidence, ahead of any final guidance.
Ambient Voice AI Just Crossed the Medical Device Line
MHRA guidance on ambient voice technology signals that clinical AI scribes and voice assistants are now squarely inside medical device regulation, not adjacent to it.
The Exemption Your CDS Tool Is Standing On Is Under Review
FDA's Section 3060 review of clinical decision support flexibilities means hospitals should stop assuming their AI-driven CDS tools sit outside device regulation.
Design Controls Were Built for Outputs, Not Agentic Reasoning
FDA's total product life cycle framework for AI-enabled devices documents data lineage and output correctness, but not the intermediate process failures unique to agentic architectures.
The Extended Clock Is Not a Reprieve
The EU AI Act's delayed enforcement dates for medical device AI give sponsors more runway, but only if they use it to align MDR/IVDR and AI Act evidence now.
The Evidence Gap Behind AI Clinical Decision Support
AI decision support tools are scaling into hospitals faster than the evidence and oversight infrastructure needed to trust them.
FDA's Postmarket AI Machinery Is Still Under Construction
Recent FDA moves on AI-enabled devices signal a postmarket framework taking shape, but the agency's own uncertainty argues against treating early engagement as a settled strategy.
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 FDA-EU Fork in AI-Enabled Medical Devices
FDA is building adaptive, lifecycle-based pathways for AI-enabled devices while the EU stacks AI Act obligations atop MDR and IVDR, forcing a sequencing decision now.
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.
FDA's GenAI Guidance Gap Puts Lifecycle Design on the Critical Path
FDA is still soliciting input on generative AI device oversight while conventional AI/ML tools keep clearing through 510(k), forcing sponsors to design lifecycle monitoring ahead of guidance.
The FDA Is Still Asking Questions. Brussels Already Moved Its Clock Once.
FDA's open genAI comment period and the EU's already-shifted AI Act deadlines argue for building the shared lifecycle core, not betting on either jurisdiction's paperwork.
FDA's Lifecycle Bet on GenAI-Enabled Devices
FDA is easing premarket friction for AI-enabled devices while shifting the real compliance burden to post-market monitoring that current guidance cannot yet catch.
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.
One Journal Article Is Not Yet an AI Audit Standard
A single peer-reviewed framework is being framed as the working audit standard for generative AI mental health tools, and compliance leads should treat that framing with more caution than the coverage suggests.
The AI Lifecycle Decision Medtech Can't Wait to Make
J&J's Monarch clearance shows predetermined change control plans already govern AI updates, a lifecycle discipline device makers need now, not after genAI guidance lands.
The PCCP Illusion: Why US Speed Doesn't Buy EU Clearance
FDA's finalized change control pathway lets AI devices update without new submissions, but the EU AI Act demands continuous oversight that PCCPs were not built to satisfy.
The PCCP Gap: FDA Lets AI Models Change, Europe Asks Which Model You Meant
FDA's finalized change control plans let AI-enabled devices update without new submissions, but EU classification law may treat the same update as a new device.
The PCCP's Global Convergence Is a Hypothesis, Not Yet a Standard
IMDRF has laid out principles for regulators to adopt predetermined change control plans, but FDA and the EU's MDR/IVDR regime remain far from aligned.
The PCCP Is the Real Clearance
FDA's predetermined change control plans, not the original device clearance, now define how far an AI-enabled medical device can drift without new review.
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.
The PCCP Is the Real Decision, Not the Generative AI Docket
FDA's Predetermined Change Control Plan guidance, not the open generative AI docket, is the mechanism sponsors must decide on now for AI-enabled devices.
The Clearance Isn't the Risk. The Change Control Plan Is.
As high-risk AI medical devices scale, the decisive diligence question shifts from FDA clearance status to what a manufacturer's change control plan permits it to alter unsupervised.
FDA's RWE Guidance Widens the Door. It Doesn't Lower the Bar.
FDA's final real-world evidence guidance broadens what device sponsors can submit, but the decision that matters is whether data pipelines can meet the traceability bar the broader door implies.
The Quality System Nobody Rebuilt Yet
FDA's living PCCP model for AI-enabled devices demands continuous evidence trails that most design control systems were never built to produce.
