Medical Innovation Exchange

RWD

FDA Seeks Input on Advancing Use of Real-World Data and Evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence     The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence. Under the fifth reauthorization of the Medical Device …

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FDA Highlights Exemptions for Real World Data-identified AEs

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) …

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