FDA Highlights Exemptions for Real World Data-identified AEs

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FDA Highlights Exemptions for Real World Data-identified AEs     On December 20, the FDA updated its Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices web page to remind manufacturers that it has granted several exemptions to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) …

FDA Highlights Exemptions for Real World Data-identified AEs Read More »