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Insight Brief
Real World Evidence for Medical Device Regulatory Submissions
Unlock the potential of Real World Data (RWD) in enhancing medical device safety and effectiveness with insights from the FDA's latest draft guidance on evaluating RWD quality for regulatory decisions
Aug 23, 2024
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  • Real World Evidence for Medical Device Regulatory Submissions

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The medical community is encouraged to leverage Real World Data (RWD) from routine clinical care to enhance the safety and effectiveness of medical devices. However, RWD has different quality controls compared to traditional clinical studies.

Download this insight brief to delve into the specifics of the recently released FDA draft guidance that provides considerations for evaluating the relevance and reliability of RWD for regulatory decision-making. 

  • Highlight key principles from the FDA's draft guidance, gaining insights into how RWD quality is assessed for generating robust Real World Evidence (RWE).
  • Discover practical scenarios where RWD can augment traditional clinical studies, providing a broader perspective on medical device safety and effectiveness.
  • Learn how this draft guidance impacts study strategies, from planning to execution, and its implications for study Sponsors.

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