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FDA publishes a draft guidance on Real World evidence

FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. The 2017 final guidance remains in effect until this draft guidance is finalized.