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

Information

Type

Guidance

Regulated products

Medical Devices, Radiation-Emitting Products

Topics

Pediatric Product Development, Premarket

Published

November 28, 2017

Last updated

April 8, 2024

Description

A guidance document for industry and FDA staff on premarket notifications for pediatric X-ray imaging devices.

Organization

Country / Region

United States

License

Other (Public Domain)

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