In a Law360 article, life sciences regulatory & compliance counsel Sarah Blankstein discussed the implications of draft guidance from the U.S. Food and Drug Administration to clarify how the agency evaluates real-world data and evidence included in medical device submissions.
Sarah explains the new draft guidance, which would replace existing 2017 guidance, adds more clarity and detail on how FDA approaches the question of whether real-world data and evidence would be fit to support the agency's decision-making for medical devices, including device approval and clearance.
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