; 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 The term analytical validity means, with respect to an in vitro clinical test, the ability of the in vitro clinical test, to identify, measure, detect, calculate, or analyze (or assist in such identification, measurement, detection, calculation, or analysis of) one or more analytes, biomarkers, substances, or other targets intended to be identified, measured, detected, calculated, or analyzed by the test. (2) Applicable standard The term applicable standard , with respect to an in vitro clinical test, means a reasonable assurance of analytical and clinical validity for its indications for use, and a reasonable assurance of safety for individuals who come into contact with such in vitro clinical test, except that such term, with respect to specimen receptacles and test instruments, means a reasonable assurance of analytical validity for its indications for use and safety for individuals who come into contact with such specimen receptacle or test instrument. (3) Clinical use The term clinical use means the operation, application, or functioning of an in vitro clinical test for the purpose for which it is intended as described in section 201(ss)(1). (4) Clinical validity The term clinical validity means the ability of an in vitro clinical test to achieve the purpose for which it is intended as described in section 201(ss)(1). (5) Component or part The term component or part means a substance, piece, part, raw material, software, firmware, labeling, or assembly, including reagents, that is intended to be included as an aspect of an in vitro clinical test described in section 201(ss)(1). (6) Develop The term develop , with respect to an in vitro clinical test, means— (A) designing, validating, producing, manufacturing, remanufacturing, labeling, advertising, propagating, importing, or assembling an in vitro clinical test