variation procedure(A variation is a change in the dossier of an authorised product. There are four different types of variations: Type IA, Type IB, Type II and Line extension. cbg-meb.nlamatsyuk)
predicate device(A predicate device (PD) is a medical device that may be legally marketed in the U.S, and used as a point of comparison for new medical devices seeking approval through FDA's 510(k) premarket clearance pathway. amatsyuk)
predicate method(т. е. метод и связанная с ним продукция, официально разрешенные к применению и имеющие оборот на рынке (контроль качества и менеджмент рисков) olga don)