Notes from the FDA frontier.
171 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
What Is GMLP? FDA’s 10 Good Machine Learning Practice Principles
Explore the FDA's GMLP principles for AI medical devices, covering development, testing, and performance monitoring to ensure safety and effectiveness.
FDA Clearance for AI Devices From Korea, Japan and Taiwan
How AI medical devices from Korea, Japan and Taiwan get FDA clearance: what carries over from MFDS, PMDA or TFDA, US data needs, PCCPs and review times.
AI Tool Validation Under the QMSR: How to Validate AI Tools and Keep Audit Trails
How to validate AI tools under the QMSR: FDA’s 2026 software assurance guidance, risk levels, what to record, Part 11 audit trails and AI model changes.
FDA Clearance for Indian Manufacturers: The Complete 510(k) Path
Navigate the FDA clearance process for Indian manufacturers with insights on 510(k) requirements, costs, and timelines essential for U.S. market entry.
FDA Clearance for Japan Manufacturers: The Complete 510(k) Path
Explore the essential steps for Japanese manufacturers to achieve FDA 510(k) clearance, including requirements, timelines, and costs for entering the U.S. market.
FDA Clearance for Malaysian Manufacturers: The Complete 510(k) Path
Learn about the 510(k) clearance process for Malaysian manufacturers, focusing on medical gloves, FDA requirements, and essential testing standards.
FDA Clearance for South Korean Manufacturers: The Complete 510(k) Path
Navigate the FDA 510(k) clearance process for South Korean manufacturers, understanding requirements, costs, and timelines for successful market entry in the US.
FDA Clearance for Taiwan Manufacturers: The Complete 510(k) Path
Discover the essential steps for Taiwanese manufacturers seeking FDA 510(k) clearance, including costs, timelines, and the role of TFDA licenses.
FDA Clearance for Turkey Manufacturers: The Complete 510(k) Path
Discover essential insights on FDA 510(k) clearance for Turkish manufacturers, including requirements, costs, and timelines for successful US market entry.
Does FDA Accept Foreign Test Reports? Using Non-US Lab Reports
Discover how to use foreign test reports in a 510(k) submission, including FDA guidelines, acceptable standards, and essential documentation requirements.
FDA 510(k) Review Times by Country (2023-2026 Data)
Explore the latest data on FDA 510(k) review times by country, revealing significant variations and insights to streamline your submission process.
Class II Medical Devices: Examples, Requirements and the 510(k) Path
Explore the essential insights on Class II medical devices, their requirements, examples, and the 510(k) pathway for FDA clearance. Stay informed on regulations and trends.
FDA Q-Submission Consulting: When You Need Pre-Sub Help and What Good Looks Like
Discover the essentials of FDA Q-Submission consulting for Pre-Submissions, including when to seek help and what constitutes an effective submission.
FDA Software Documentation Level: Basic vs Enhanced
Learn how to determine the FDA software documentation level for your device submissions—Basic or Enhanced—and ensure compliance with the latest guidelines.
Sterility, Packaging and Shelf Life in a 510(k): FDA Rules
Understand FDA 510(k) requirements for sterility, packaging, and shelf life. Learn about validation methods and essential documentation for device clearance.
When Does a 510(k) Need Clinical Data? FDA Rules and Data
Discover when clinical data is required for a 510(k) submission, key FDA guidelines, and insights from device evaluations to streamline your market entry.
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.
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.