Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.