Premarket Assessment of Pediatric Medical Devices: Guidance for Industry and FDA Staff

Information

Type

Guidance

Regulated products

Biologics, Medical Devices

Topics

Pediatric Product Development, Premarket

Published

March 24, 2014

Last updated

April 11, 2024

Description

This document is a guidance for industry and FDA staff on premarket assessment of pediatric medical devices.

Organization

Country / Region

United States

License

Other (Public Domain)

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