Notes from the FDA frontier.
155 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
FDA Small Business Designation: How to Get Reduced Fees
Learn how to qualify for the FDA's small business designation, which offers significant fee reductions for device submissions. Save on costs and streamline your process.
Complizen vs FDA 510(k) Consultants for Faster Clearance
Explore how Complizen's regulatory AI software streamlines the 510(k) submission process, enhancing efficiency while retaining essential human expertise.
FDA Has Cleared 1,614 AI Medical Devices. 96% Took the Same Path.
Explore the FDA's clearance landscape for AI medical devices, revealing key trends, market strategies, and the dominance of radiology in device approvals.
How to Automate 510(k) Submission Tracking for Medical Devices
Learn how to effectively automate 510(k) submission tracking for medical devices, optimizing deadlines and team collaboration while navigating FDA limitations.
How Long Does FDA Clearance Actually Take for a Taiwanese Manufacturer?
Discover the realistic timeline for FDA clearance for Taiwanese medical device manufacturers, including key steps, challenges, and how MDSAP can expedite the process.
Is Your CE Mark Still Valid? What the MDD to MDR Transition Actually Requires
Ensure your CE mark is still valid under the new MDR regulations. Understand the critical deadlines and what could jeopardize your device's status.
Does an MDA Registration Help With FDA Clearance? Malaysia Recognizes FDA — FDA Doesn't Recognize Malaysia
Explore the complexities of FDA and MDA regulations, highlighting the one-way recognition and what it means for medical device market entry.
Is PCCP Only for AI Devices? What Actually Qualifies for a Predetermined Change Control Plan
Explore the Predetermined Change Control Plan (PCCP) and its application beyond AI devices, understanding its components, FDA guidance, and strategic implications.
Does an MFDS Licence Help With FDA Clearance? What Transfers From Korea and What Doesn't
Explore the complexities of obtaining FDA clearance for Korean medical devices. Understand the distinctions between MFDS and FDA requirements and what truly transfers.
Do You Need an FDA 510(k) Consultant, or Can You File It Yourself?
Deciding whether to hire an FDA 510(k) consultant depends on submission frequency, predicate clarity, and in-house expertise. Learn the key factors to consider.
Does a CDSCO Licence Help With FDA Clearance? What Transfers From India and What Doesn't
Understanding the differences between CDSCO and FDA regulations is crucial for Indian medical device manufacturers seeking U.S. market entry and compliance.
Why CE Mark Is Getting More Complex and More Expensive
The CE Mark process is becoming more complex and costly due to stricter regulations and limited notified bodies, impacting innovation and compliance for manufacturers.
Your Regulator Probably Isn't a WHO Listed Authority. Here's Why That Now Matters for Exports.
Explore the significance of WHO's new list of transitional Listed Authorities for medical devices and its impact on global export strategies.
FDA 510(k) Third Party Review Program: Everything You Need to Know
Discover the FDA's 510(k) Third Party Review Program, its benefits, eligibility criteria, and the review process for low-to-moderate risk medical devices.
Free Sale Certificate for Medical Devices: How FDA's CFG-NE Actually Works
Understand the FDA's Free Sale Certificate process, specifically the CFG-NE, required for medical devices sold internationally without US export.
AI and ISO 14971: What Belongs in Your Risk Management File (and What Doesn't)
Using AI for 510(k) submissions can lead to serious errors. Learn the risks and best practices to ensure accurate and compliant regulatory documents.
Using AI to Draft Your 510(k)? Here's What Actually Goes Wrong
Using AI for 510(k) submissions can lead to serious errors. Learn the risks and best practices to ensure accurate and compliant regulatory documents.
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.