Notes from the FDA frontier.
171 posts and counting — every CDRH guidance, warning letter, and explainer worth your time.
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.
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.
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.
FDA Performance Testing Requirements: Complete Bench, Software, and Biocompatibility Guide
Discover the essential FDA performance testing requirements for your device. This complete guide covers bench, software, and biocompatibility testing, ensuring compliance with FDA performance testing standards.
Human Factors Engineering for Medical Devices: Complete FDA Usability Guide
Explore the essential guide on human factors engineering for medical devices. Understand FDA's expectations on human factors engineering for device safety.
FDA Consensus Standards for Medical Devices: US Declaration of Conformity Complete Guide
FDA consensus standards guide: Declaration of Conformity requirements, 2025 updates, strategic selection, and submission optimization. Accelerate FDA review with proper DOC implementation.
Medical Device Packaging Requirements: Complete FDA, ISO 11607 & Validation Complete Guide
Ensure your medical device packaging meets FDA standards in 2025. Learn how to avoid costly delays with expert insights on medical device packaging.
Clinical Evidence for SaMD: Valid Association, Analytical & Clinical Validation
Learn how to design and structure clinical evidence for SaMD—study types, endpoints, reporting formats.
FDA Software Validation: What Evidence to Show Complete Guide
Discover the precise software validation evidence FDA requires for SaMD—test plan, code coverage, risk-based testing, and automated checks.