Notes from the FDA frontier.
153 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
Does My Mobile Health App Need FDA Approval or Clearance? When Your iOS/Android App Is a Medical Device Explained
Discover if your Mobile Health App needs FDA approval. Learn when a Mobile Health App is considered a medical device and the steps to compliance.
FDA Clearance Is a Global Strength. Here’s Why It Matters Beyond the U.S.
Discover why FDA clearance is a global strength beyond the U.S. and how FDA can enhance your market credibility and business growth worldwide.
AI Tools for FDA Medical Device Submissions: What Works, What Doesn't, and How to Use Them Safely
Discover how AI tools can streamline FDA medical device submissions. Learn what works, what doesn't, and how to use AI tools safely today.
Geopolitics Is Becoming a Regulatory Problem
Explore how geopolitics is reshaping regulatory challenges. Discover why understanding regulatory strategy is crucial in today's global market.
10 Expensive Mistakes International Medical Device Manufacturers Make Entering the US Market
Avoid costly errors with international medical device market entry. Learn key mistakes international medical device manufacturers make and how to avoid them.
Can I Use My CE Mark Clinical Data for FDA 510(k)? Complete Guide
Discover if your CE Mark clinical data can be used for FDA 510(k) submissions. Learn how to leverage CE Mark data effectively in this guide.
Why More International Medical Device Manufacturers Are Entering The US Market
Discover how medical device tariffs are reshaping the industry, creating new FDA entrants. Learn how medical device tariffs impact global markets.
CE Mark vs FDA 510(k): EU MDR and US Regulatory Pathway Comparison
Explore the comprehensive guide on CE Mark vs FDA 510(k) regulatory pathways. Understand CE Mark FDA differences, requirements, and strategic insights.
How to Reduce Medical Device Clinical Trial Costs: Proven Strategies
Learn proven strategies to reduce clinical trial costs for medical devices. Discover how strategic planning and FDA engagement can save millions in clinical trials.
Kintsugi Didn’t Fail on AI. It Failed on Regulatory Economics.
Discover why Kintsugi's failure wasn't about AI, but regulatory economics. Learn how regulatory hurdles impact clinical AI businesses like Kintsugi.
Are there any AI tools for FDA 510(k) Submissions: What Works, What Doesn't
Yes, AI-powered tools can help with parts of an FDA 510(k) submission. Learn where AI adds value, where human judgment is still required, and how teams use AI responsibly.
Entering The U.S. Medical Device Market Isn’t As Hard As Many International Teams Expect
Discover how entering the U.S. medical device market can be easier than expected. Learn key insights for international teams entering the U.S. medical device market.
How Much Do Medical Device Clinical Trials Cost? Complete Budget Breakdown
Discover the detailed costs of Clinical Trials for medical devices. Learn how to budget accurately for Clinical Trials to avoid overspending.
Regulatory Isn’t Slow Because It’s Complex. It’s Slow Because It’s Fragmented.
Regulatory work isn’t slow because it’s complex. It’s slow because information is fragmented, forcing teams to search, rework, and reset instead of making progress.
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.
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.
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.
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.
EU MDR vs FDA: US-EU Medical Device Regulatory Comparison Guide
EU MDR vs FDA complete comparison 2025. CE marking vs 510(k) timelines, costs, requirements. Strategic market entry guide for medical device companies
How to Fund a Medical Device Startup: Complete Guide (Grants, Angels, VC & Non-Dilutive Options)
Complete medical device startup funding guide. Grants, VC, angels, crowdfunding options. $305K-$100M+ funding strategies and timelines.
How to Fund a Medical Device Startup: Complete Guide (Grants, Angels, VC & Non-Dilutive Options)
Complete medical device startup funding guide. Grants, VC, angels, crowdfunding options. $305K-$100M+ funding strategies and timelines.
How To Bring A Medical Device To Market: Complete Step-by-Step Guide
Medical device product development process: 5 phases from concept to launch. Complete 2025 guide with timelines, costs, regulatory requirements, and success strategies.
How Much Does It Cost to Bring a Medical Device to Market? Complete Budget Guide
Discover the true medical device cost to market. Avoid funding shortfalls with realistic medical device cost estimates from industry experts.