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Unapproved Product

Date of Publication

2/27/2008

Definition

A medical product that has not been approved by the FDA for general commercial marketing or that the FDA has determined may not be used for its intended purpose without an Emergency Use Authorization or under rules applicable to investigational new drugs or investigational devices.

Source of Definition

DoD Instruction 6200.02: Application of FDA Rules to Department of Defense Force Health Protection Programs

Related Glossary Terms

Unapproved Product

Last Updated: August 01, 2022

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