; 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 ; and (2) by adding at the end of chapter V the following: J In Vitro Clinical Tests 587. Definitions In this subchapter: (1) Analytical validity (A) The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to— (i) sufficiently identify, measure, detect, calculate, or analyze one or more analytes, biomarkers, substances, or other targets intended to be identified, measured, detected, calculated, or analyzed by the test; or (ii) as applicable, assist in such identification, measurement, detection, calculation, or analysis. (B) For an article for taking or deriving specimens from the human body described in section 201(ss)(1)(B)(iii), the term analytical validity means that such article performs as intended and will support the analytical validity of an in vitro clinical test with which it is used. (2) Applicable standard The term applicable standard , with respect to an in vitro clinical test, means a reasonable assurance of analytical and clinical validity, except that such term— (A) with respect to test instruments, means a reasonable assurance of analytical validity