Preferred Label : De Novo Classification Request;
Alternative definition : FDA: 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.;
Origin ID : C121843;
UMLS CUI : C4055162;
Semantic type(s)
- concept_is_in_subset
