FDA Post-Market Surveillance (PMS) for Medical Devices
FDA Post-Market Surveillance (PMS) is a regulatory requirement under 21 CFR Part 822, designed to ensure the long-term safety and effectiveness of medical devices after they have been released into the market. It helps manufacturers identify potential risks, track real-world device performance, and take necessary corrective actions to maintain compliance with FDA PMS regulations. What is FDA Post-Market Surveillance (PMS) for Medical Devices? FDA PMS refers to the systematic monitoring of medica...
