Notes from the FDA frontier.
153 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
Software as a Medical Device (SaMD) Explained: What It Is, FDA Requirements, and How to Get Cleared
Explore the world of software as a medical device, understand FDA requirements, and learn how to get your software as a medical device cleared efficiently.
How the FDA Reviews AI and Machine Learning Medical Devices: Complete Guide
How FDA reviews AI and machine learning medical devices. Learn about PCCPs, submission requirements, and regulatory strategies for AI device approval.
How the FDA Reviews AI and Machine Learning Medical Devices: Complete Guide
How FDA reviews AI and machine learning medical devices. Learn about PCCPs, submission requirements, and regulatory strategies for AI device approval.
FDA PCCP vs EU AI Act for AI/ML Medical Devices: US–EU Medical Device Strategy
Discover the strategic differences between the EU AI Act and FDA PCCP for AI medical devices. Navigate AI medical device compliance effectively.
What Is EU AI Act? Medical Device Compliance Guide
Navigate the complexities of the EU AI Act with our 2025 Medical Device Compliance Guide. Understand EU AI Act requirements to ensure compliance.
What Is IMDRF? Complete AI/ML & SaMD Guide (N88 GMLP + N81 Risk)
IMDRF's new 2025 AI guidance (N88 & N81) sets global standards for AI medical devices. Learn the 10 GMLP principles + implementation roadmap.
Predetermined Change Control Plan (PCCP) for AI/ML-Enabled Devices: FDA Guide
Build an FDA-ready PCCP for AI devices: what to include, what’s in scope, where it goes in 510(k)/De Novo/PMA, labeling notes, and common pitfalls (2025).
AI Medical Devices: FDA Draft Guidance, TPLC & PCCP Complete Guide
Discover the essential guide to AI Medical Device regulations with the FDA's updates. Learn how AI Medical Device compliance can accelerate innovation.
AI Medical Devices: FDA Draft Guidance, TPLC & PCCP Complete Guide
Discover the essential guide to AI Medical Device regulations with the FDA's updates. Learn how AI Medical Device compliance can accelerate innovation.
FDA Cybersecurity Compliance Standards: Complete Medical Device Guide
Discover the essential Cybersecurity Compliance Standards to protect your medtech business from criminal penalties and ensure FDA approval.
FDA Cybersecurity Compliance Standards: Complete Medical Device Guide
Discover the essential Cybersecurity Compliance Standards to protect your medtech business from criminal penalties and ensure FDA approval.
What Is an SBOM? FDA Requirements for Medical Devices Complete Guide
SBOM compliance required for FDA medical device software submissions. Learn requirements that determine approval success and cybersecurity compliance.
Top Reasons SaMD 510(k)s Get AI Letters (and How to Fix Them)
Discover why SaMD 510(k) submissions fail. Cybersecurity gaps, AI/ML validation issues & predicate problems leading 2025 rejections. Expert analysis.
SaMD vs SiMD: Quick Comparison for Medical Devices
Learn the critical differences between SaMD and traditional medical device software, FDA classifications, and regulatory pathways in 2025.
Good Machine Learning Practice (GMLP): What It Is & Who Must Follow It
Discover FDA’s GMLP framework for SaMD—key principles, lifecycle steps, and who must comply.
Documenting AI-Enabled SaMD: What FDA Expects
Learn how to document your AI/ML model for SaMD per FDA’s January 2025 draft: required sections, data lineage, performance metrics, and PCCP examples.
Documenting AI-Enabled SaMD: What FDA Expects
Learn how to document your AI/ML model for SaMD per FDA’s January 2025 draft: required sections, data lineage, performance metrics, and PCCP examples.
FDA SaMD Cybersecurity: §524B, SBOM, Testing & eSTAR Complete Guide
Learn FDA’s cybersecurity requirements for SaMD: SBOM, threat modeling, secure design, and validation.
FDA SaMD Cybersecurity: §524B, SBOM, Testing & eSTAR Complete Guide
Learn FDA’s cybersecurity requirements for SaMD: SBOM, threat modeling, secure design, and validation.
IEC 62304 + ISO 14971 for SaMD: How to Integrate Lifecycle & Risk
Learn how to align IEC 62304 software lifecycle processes with ISO 14971 risk management for FDA-compliant SaMD development.
Which FDA Pathway for SaMD? 510(k), De Novo, or PMA - Complete Medical Device Guide
Learn when SaMD needs a 510(k), when De Novo applies, and when FDA requires a PMA.
SaMD Risk Categories (IMDRF): What They Mean & How They Relate to FDA Review
Learn the IMDRF SaMD risk categories, how they map to FDA Class I-III, and which levels trigger 510(k), De Novo, or PMA review.
Device Software Function (DSF): FDA’s AI Draft Definition
Learn how FDA’s draft guidance defines “device software function” and why it matters for AI devices.
Device Software Function (DSF): FDA’s AI Draft Definition
Learn how FDA’s draft guidance defines “device software function” and why it matters for AI devices.