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.
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.
FDA’s Latest Warning Letter Mentions AI. Here’s What Actually Matters.
FDA cited AI in a warning letter. Here is what actually happened, why the company failed, and what it means for every team using AI in regulated work.
What Is My Medical Device Classification? FDA Medical Device Classification Class I, II, III Explained
Understand FDA classification for medical devices with our comprehensive guide. Discover how FDA classification impacts your device's pathway.
How to Register Your Medical Device Company with FDA: FURLS Setup, Fees, FDA registration and Device Listing
Learn how to complete FDA registration for your medical device company efficiently. Navigate FURLS setup, fees, and device listing with ease.
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.
FDA Additional Information Requests: How to Respond to 510(k) Deficiency Letters (Complete Guide)
Learn how to effectively respond to FDA Additional Information requests for 510(k) deficiency letters. Master strategies to address FDA Additional Information requests and meet the 180-day deadline.
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.
Biocompatibility Testing for Medical Devices: Complete ISO 10993 Guide
Explore our comprehensive guide on biocompatibility testing for medical devices. Learn how ISO 10993 ensures biocompatibility and safety compliance.
Medical Device Recalls: Complete Medical Device FDA Compliance Guide
Discover everything you need to know about medical device recall processes and FDA compliance. Learn how to manage a medical device recall effectively.
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.
US Agent Requirements for International Medical Device Manufacturers: Complete Guide
Discover everything about US Agent requirements for international medical device manufacturers. Ensure compliance by appointing a US Agent today!
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.
How to Prepare for an FDA Inspection: Complete Readiness Guide
Prepare for an FDA inspection with this comprehensive guide. Learn how to handle FDA inspections, close CAPA gaps, and respond effectively.
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.
Which Sterilization Method Should I Use for My Medical Device? Complete Selection Guide
Discover the best Sterilization method for your medical device with our complete guide. Learn about Sterilization options, material compatibility, and validation.