Labelling of Devices for Investigational Use

Devices intended for clinical investigations must bear the following statement on the labelling CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.  

Devices intended solely for research on or with laboratory animals should be labelled with CAUTION - Device for investigational use in laboratory animals or other tests that do not involve human subjects.  

In-vitro diagnostic reagents for field trial studies should bear the statement For Investigational Use Only. The performance characteristics of this product have not been established.  

Reports of previous investigations and a summary of the proposed investigational plan or the plan itself. 

A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of the device 

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