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Clinical trials addressing high-risk pediatric medical devices used in children.

United statesKyar shutterstockDrug administrationInternational organization for standardizationPediatric researchSai thawCoordinating researchMedical devicesEuropean medical device regulationPremarket approvalsYearly reportsPremarket authorizationPediatric usageHumanitarian device exemptionNorth americaInternational organization