Notes from the FDA frontier.
154 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
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.
Digital Health Regulation: What Actually Changed at FDA
FDA updates in January redefine digital health regulations, allowing wearables to claim physiological data under wellness guidelines and clarifying software support for clinicians.
Is Your Clinical Decision Support Software Exempt From FDA Regulation? What Changed in January
Discover the updated FDA guidance on clinical decision support software exemptions and how to navigate the four key criteria for compliance.
Does a PMDA Approval Help With FDA Clearance? Japan Recognizes FDA for Priority Review
Explore the nuances of PMDA approval and its limited impact on FDA clearance, alongside Japan's new regulatory recognition for priority review of medical devices.
FDA First or CE Mark First? How to Decide
Deciding between FDA and CE Mark first? Explore key factors like timelines, costs, and market access strategies to make the best choice for your device.
Does a TFDA Licence Help With FDA Clearance? Taiwan Recognizes FDA — FDA Doesn't Recognize Taiwan?
Understanding the TFDA and FDA relationship is crucial for Taiwanese manufacturers. This blog details how a TFDA licence impacts FDA clearance and highlights key regulatory distinctions.
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.
Does CE Mark Help With FDA Approval? What Transfers to a 510(k) and What Doesn't
Explore how CE Mark impacts FDA 510(k) submissions, what evidence can be reused, and essential strategies for successful U.S. market entry.
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.
Does Your Medical Device Company Need an AI Use Policy? What ISO 13485 Actually Requires
Find the right predicate device for your 510(k) submission. Step-by-step guide to FDA database search, evaluation criteria, and avoiding costly mistakes.
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.