predicate products

[marijka]

The extent of testing that is performed for medical devices depends on the following factors: - the similarity and uniqueness of the product relative to previously marketed ("predicate") products ...

Я все понимаю, я сказать по-русски не могу.

Примечание по теме, но это не контекст из моего текста:
If the sponsor believes its product is substantially equivalent to a predicate device (one marketed prior to 1976 or one that has been classified by FDA as not requiring premarket approval), the sponsor submits a premarketing notification document (commonly known as a 510(k)) to the FDA.