ABSTRACT
The FDA classifies IVD products as devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&CA). They may also be biological products subject to Section 351 of the Public Health Service Act (PHSA). The PHSA defines a biological product as any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood compound or derivative, allergenic product or analogous product, or arsphenamine or its derivatives (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of humans (Public Law 78410 §262).
