FDA Updates Real-World Data-Based Medical Device Adverse Event Reporting

The US Food and Drug Administration (FDA) has issued an update to its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices website highlighting exemptions to its medical device reporting (MDR) requirements. The changes involve reporting of adverse events identified via real-world data (RWD). These exemptions are contingent on submission of summary medical device reports.

According to MedTech Intelligence, “The FDA uses MDR as a postmarket surveillance tool to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of medical devices.”

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(Source: MedTech Intelligence, December 20^th, 2022)