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If the FDA determines that a new device is not substantially equivalent to a pre-amendment device , the new device is automatically designated a Class III medical device and the sponsor is required to obtain pre-marketing approval from the FDA . And the same thing befalls a man who endeavours to demonstrate the mysteries of Faith by naturall reason , which happens to a sick man , who will needs chew before he will swallow his wholsome , but bitter Pills ; whence it comes to passe , that he presently brings them up againe , which perhaps would otherwise , if he had taken them well downe , have prov 'd his remedy . If the new device is deemed substantially equivalent to a pre-amendments device , it may be marketed immediately and is regulated in the same regulatory class as the pre-amendments device to which it is equivalent . The malaria-causing Plasmodium has a complex life cycle . If the new device is deemed not to be substantially equivalent to a pre-amendments device , it must undergo clinical testing and pre-market approval before it can be marketed unless it is reclassified into a lower regulatory class . The first site is Treasures@Sea: Exploring the Ocean Through Literature , an extensive Web resource consisting of Web-based learning activities that integrate language arts with oceanography . The FDA reviews these notifications to determine if the new device is " substantially equivalent " to a device that was marketed prior to passage of the Amendments ( i.e ., a " pre-amendment device " ) . The third issue pertains to the need for greater coordination in the organ and tissue donation community so as to facilitate intra-community communication for exchange of information and experiences regarding donor registries .