Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff November 2017

GUIDANCE DOCUMENT

• Docket Number: FDA-2012-D-0384
• Issued by: Center for Devices and Radiological Health

This guidance document outlines the current thinking of the Food and Drug Administration (FDA or the Agency) regarding information that should be provided in premarket notification submissions (510(k)s) and device labeling for x-ray imaging devices that are indicated for pediatric populations or general use x-ray imaging devices for which considerable pediatric application is anticipated. General use x-ray imaging devices typically neither include nor exclude specific populations in the indications for use and may be expected to be used in any population Because a large percentage of the hundreds of millions of x-ray examinations performed annually in the US are exams of pediatric patients, FDA expects that most general use x-ray imaging devices will be used for a considerable quantity of pediatric examinations unless a device’s design precludes use in smaller sized patients. This guidance is intended to enhance clarity regarding the premarket review process of 510(k)s for x-ray imaging devices, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations regarding labeling, including the instructions for use.

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