Post-Market Surveillance
26 articles
FDA Form 483 and Warning Letter Guide: How to Respond and Protect Your Medical Device Business
Learn how to respond to FDA Form 483 observations and Warning Letters for medical devices. Covers 2025-2026 enforcement statistics, top violations, response strategies, and the March 2026 draft guidance on 483 responses.
FDA Medical Device Recalls: Complete Guide to Corrections, Removals, and Recall Classification (21 CFR 7, 806, 810)
Comprehensive guide to FDA medical device recalls — voluntary vs mandatory recalls, Class I/II/III classification, corrections and removals under 21 CFR 806, reporting requirements, recall strategy, health hazard evaluation, and compliance best practices.
FDA Medical Device Reporting (MDR): Complete Guide to Adverse Event Reporting Under 21 CFR Part 803
Comprehensive guide to FDA Medical Device Reporting (MDR) — who must report, what events are reportable, 30-day and 5-day timelines, eMDR electronic submission, complaint handling integration, MAUDE database, and enforcement risks.
Post-Market Clinical Follow-Up (PMCF) Under EU MDR: Plans, Studies, and the Complete Implementation Guide
A comprehensive guide to PMCF under EU MDR — covering PMCF plan development, study design, evaluation reports, integration with PMS and clinical evaluation, and practical implementation strategies.
FDA MAUDE Database: The Complete Guide to Searching and Using Medical Device Adverse Event Reports
How to search, interpret, and use the FDA MAUDE database — report types, data fields, search techniques, limitations, and practical applications for regulatory professionals.
Post-Market Surveillance for Medical Devices: The Complete Guide
Everything you need to know about post-market surveillance (PMS) for medical devices — regulatory requirements under FDA and EU MDR/IVDR, PMS plan templates, PMCF studies, PSURs, vigilance reporting, and practical guidance for building a PMS system from scratch.