FDA

In the U.S., shipment of temperature sensitive articles is regulated by the Food and Drug Administration (FDA) (www.fda.gov).   Our facility produces Class II devices for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls.  Special controls may include special labeling requirements and mandatory performance standards.