Notes from the FDA frontier.
153 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
How Long Does It Take to Bring a Medical Device to Market?
Discover how long it takes to bring a device to market. Learn about timelines, delays, and strategies to efficiently bring a device to market.
FDA Performance Testing Requirements: Complete Bench, Software, and Biocompatibility Guide
Discover the essential FDA performance testing requirements for your device. This complete guide covers bench, software, and biocompatibility testing, ensuring compliance with FDA performance testing standards.
What Happens If FDA Disagrees With Your Predicate Device? Complete Response Guide
Discover what happens if FDA disagrees with your predicate device and explore response strategies. Learn how to navigate predicate device challenges effectively.
Human Factors Engineering for Medical Devices: Complete FDA Usability Guide
Explore the essential guide on human factors engineering for medical devices. Understand FDA's expectations on human factors engineering for device safety.
Do I Need a New 510(k) for a Device Change? FDA Decision Guide (2026)
Discover when a device modification requires a new 510(k) with our complete FDA decision guide. Ensure compliance with device modification rules.
How Much Does a 510(k) Cost? Complete Budget Breakdown
510(k) costs range from $50K-$250K+ depending on device complexity. Complete breakdown of FDA fees, testing costs, consultants, and hidden expenses.
10 Reasons FDA Submissions Fail — Even When You Think You're Ready
Why 60% of 510(k)s get RTA'd. The top 10 preventable reasons FDA submissions fail, backed by data and regulatory expert analysis for 2025.
How to Build a Medical Device Regulatory Strategy: Complete Guide
Build a winning medical device regulatory strategy. Pathway selection, resource planning, timeline optimization, and risk mitigation frameworks.
How to Bring a Medical Device to the U.S. Market: Complete 2026 Guide
Complete roadmap for U.S. medical device market entry. FDA pathways, timelines, costs, and decision frameworks to avoid expensive mistakes in 2025.
FDA Third-Party Review (3P510k): The Overlooked Route to Faster 510(k) Clearance (Complete Guide)
Learn how the FDA’s Third-Party Review program can speed up 510(k) clearance for eligible devices.
How to Prepare Your First FDA Submission: Step-by-Step Guide
Complete guide to preparing your first FDA submission as a startup founder. Learn classification, pathway selection, documentation, and timelines for 2025.
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.
What Is a Design History File (DHF)? Complete Guide
Complete Design History File (DHF) guide 2025. Learn FDA requirements, contents, creation process, and audit preparation. Essential for medical device compliance.
What Is FDA Device Registration and Listing? Complete Guide
FDA device registration and listing guide 2025. Learn requirements, deadlines, fees, and avoid costly delays. Step-by-step process + expert tips.
FDA Inspection Preparation Checklist: Complete Medical Device Guide
How to pass your next FDA inspection: front/back room playbook, 15-day 483 response, QMSR (2026) changes, RRAs and eSTAR rules, plus a checklist.
FDA Compliance for Medical Devices: Complete Beginner's Guide
A practical step by step path to FDA compliance: classify your device, pick the pathway, use eSTAR, build QMS to QMSR, register/list, label with UDI, and meet MDR reporting.
What are Combination Products? FDA Medical Device Guide
Learn what combination products are, examples, FDA classification rules, and PMOA determination. Avoid the costly mistakes that derail medical device startups.
What are Combination Products? FDA Medical Device Guide
Learn what combination products are, examples, FDA classification rules, and PMOA determination. Avoid the costly mistakes that derail medical device startups.
How to Find a Predicate Device: Complete FDA Medical Device Guide
Find the right predicate device for your 510(k) submission. Step-by-step guide to FDA database search, evaluation criteria, and avoiding costly mistakes.
How To Import Medical Devices: FDA Initial Importer Complete Guide
Import medical devices to US with FDA compliance. Avoid detention/refusal with complete requirements guide for foreign manufacturers and importers.
Medical Device Labeling Requirements: Complete FDA 21 CFR 801 Compliance Guide
FDA medical device labeling requirements under 21 CFR 801. Avoid warning letters with UDI, QSR controls, and compliance strategies.
Do I Need FDA Approval, Clearance, or Exemption? Medical Device Guide
Determine if your medical device needs FDA approval, clearance, or exemption. Save time and money with the right regulatory pathway. Complete decision guide.
CMS NTAP for AI Medical Devices: US Inpatient Reimbursement Guide
CMS New Technology Add-on Payment (NTAP) provides Medicare payments for AI medical devices. October 2025 deadline approaching. Complete application strategy guide.