Notes from the FDA frontier.
153 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
What Is an FDA Pre-Submission (Q-Sub)? Complete Guide
Learn when FDA Q-Submissions provide ROI for medical device approvals. Complete guide to Pre-Subs, timing strategy, eSTAR requirements & maximizing FDA feedback value.
Humanitarian Device Exemption (HDE): Complete FDA Guide
Learn FDA's Humanitarian Device Exemption (HDE) pathway for rare disease devices affecting ≤8,000 patients. Complete guide to HUD designation, profit restrictions & IRB requirements.
Humanitarian Device Exemption (HDE): Complete FDA Guide
Learn FDA's Humanitarian Device Exemption (HDE) pathway for rare disease devices affecting ≤8,000 patients. Complete guide to HUD designation, profit restrictions & IRB requirements.
What Is an IDE? FDA Investigational Device Exemption Complete Guide
Learn when you need FDA Investigational Device Exemption (IDE) for clinical studies. Complete guide to significant risk vs nonsignificant risk devices & approval process.
What Is an IDE? FDA Investigational Device Exemption Complete Guide
Learn when you need FDA Investigational Device Exemption (IDE) for clinical studies. Complete guide to significant risk vs nonsignificant risk devices & approval process.
What Is FDA's Breakthrough Devices Program? Complete Guide
FDA's Breakthrough Devices Program expedites review by 6-12 months for qualifying medical devices. Learn eligibility requirements, benefits & application strategy.
What Is FDA's Breakthrough Devices Program? Complete Guide
FDA's Breakthrough Devices Program expedites review by 6-12 months for qualifying medical devices. Learn eligibility requirements, benefits & application strategy.
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.
FDA De Novo Pathway Explained: The Complete Guide
Master the FDA De Novo pathway for novel medical devices. Learn costs, timelines, eligibility criteria & success strategies. Complete guide.
Pre-market Approval (PMA) Explained: The Complete Guide
Learn what PMA premarket approval is, when medical devices need PMA, and how the FDA approval process works. Complete guide.
FDA 510(k) Clearance Explained: How It Works (Complete Guide)
Learn about FDA 510(k) clearance and how it works. Our complete guide simplifies the FDA 510(k) process for medical device approval.
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.
The Gentle Singularity in Life Sciences: What Sam Altman's AI Timeline Means for Medical Innovation
Sam Altman just released "𝘛𝘩𝘦 𝘎𝘦𝘯𝘵𝘭𝘦 𝘚𝘪𝘯𝘨𝘶𝘭𝘢𝘳𝘪𝘵𝘺": his take on where AI stands today and where it's headed. This article breaks all that down and how it impact life sciences.
510(k) vs De Novo vs PMA: How to Choose the Right Pathway Complete Guide
Confused between 510(k), De Novo, or PMA? This guide breaks down each FDA pathway—timelines, costs, risks, and how to choose the right one.
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.
Clinical Evidence for SaMD: Valid Association, Analytical & Clinical Validation
Learn how to design and structure clinical evidence for SaMD—study types, endpoints, reporting formats.
FDA Software Validation: What Evidence to Show Complete Guide
Discover the precise software validation evidence FDA requires for SaMD—test plan, code coverage, risk-based testing, and automated checks.
FDA Software Validation: What Evidence to Show Complete Guide
Discover the precise software validation evidence FDA requires for SaMD—test plan, code coverage, risk-based testing, and automated checks.
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.
FDA SaMD Pre-Submission (Q-Sub): When to Request & What to Include
Learn when to schedule an FDA Pre-Submission meeting for your SaMD project, key benefits, required documents.