; and (2) by adding at the end the following: (B) The term biological product does not include an in vitro clinical test as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act. . (c) In vitro clinical test definition In this Act, the term in vitro clinical test has the meaning given such term in section 201(ss) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a). 3. Regulation of in vitro clinical tests The Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq. ) is amended— (1) by amending the heading of chapter V to read as follows: Drugs, Devices, and In Vitro Clinical Tests