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FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing Authorization | Morgan Lewis

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under.

Morgan lewisDrug administrationTransition guidanceFederal registerQuality system regulationMedical device reportingUnique device identificationEnforcement policy draft transition guidance

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