Draft Guidance for Industry and FDA Staff; Premarket Assessment of Pediatric Medical Devices; Availability

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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Premarket Assessment of Pediatric Medical Devices." This draft guidance presents FDA's current thinking on the type of safety and effectiveness information needed to support marketing of pediatric devices and on measures to be used to help protect this vulnerable patient population during the course of clinical trials involving such products. This draft guidance is neither final nor is it in effect at this time.