A FDA C106039 FDA CDRH GUDID Terminology C121843 De Novo Classification Request A premarket submission made to the FDA for classification of a device for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device. A premarket submission made to the FDA for classification of a device for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.