When Worlds Collide: The Theory of Real-World Evidence Meets Reality
The FDA Law Blog
MAY 13, 2024
Based on a review of premarket submissions made in 2012 through 2019, FDA identified 90 examples of 510(k)s, De Novos, HDEs, and PMAs approved/cleared which utilized RWE in support of regulatory decision-making. Every use of ESD is recorded, as is every behavior that falls within the intended use.
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