Once a medical device undergoes FDA’s premarket review process, its manufacture and performance are tightly controlled and monitored through a series of postmarket requirements. FDA’s postmarket regulations encompass every aspect of a device’s manufacture – from production and processing to packaging and distribution – and require manufacturers to record, monitor and analyze their processes. As part of these requirements, medical device manufacturers must establish and maintain a comprehensive "quality system" to ensure their devices are manufactured consistently to specifications and have in place reporting mechanisms to detect, identify and mitigate device-related issues.

Mandatory adverse event reporting requirements provide a mechanism for manufacturers and other stakeholders to detect issues in a timely manner and report them to FDA. Medical device manufacturers must also establish comprehensive recall procedures so that if a device experiences a serious problem once on the market, it can be addressed quickly and effectively. Finally, for some higher-risk products, additional postmarket surveillance and tracking requirements may apply to provide an added level of safety monitoring.

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Post-Market Device Issues

FDA Fact Sheets

FDA requirements for medical technology (Infographic)