Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Premarket

Published

May 8, 2019

Last updated

May 7, 2019

Description

This document is a guidance for industry and FDA staff on using animal studies to evaluate organ preservation devices in premarket stage.

Organization

Country / Region

United States

License

Other (Public Domain)

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