5 articles
A practical comparison of Japan PMDA and U.S. FDA medical device regulation, covering review bodies, classification, approval pathways, post-market obligations, and monitoring priorities.
A detailed guide to FDA 510(k) clearance — covering predicate device selection, submission types, review timelines, common pitfalls, and post-clearance obligations for medical device manufacturers.
A detailed comparison of the FDA 510(k)/PMA process and EU MDR/CE marking pathway, covering classification systems, review timelines, and post-market requirements.
A practical guide to monitoring FDA medical device recalls using openFDA, MedWatch, MAUDE, and FDA Enforcement Reports — and why real-time monitoring matters for patient safety and compliance.
A comprehensive guide to NMPA medical device registration in China, comparing the CMDE review process, classification system, and clinical requirements with the FDA pathway.