; and (B) with respect to articles for taking or deriving specimens from the human body for purposes described in clause (i) or (ii) of section 201(ss)(1)(A) means a reasonable assurance of analytical validity and, where applicable, safety. (3) Clinical use The term clinical use means the operation, application, or functioning of an in vitro clinical test in connection with human specimens, including patient, consumer, and donor specimens, for the purpose for which it is intended as described in section 201(ss)(1)(A). (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)(A). (5) Cross-referenced test The term cross-referenced test means an in vitro clinical test that references in its labeling the name or intended use of another medical product that is not an in vitro clinical test. (6) Develop The term develop , with respect to an in vitro clinical test, means— (A) designing, validating, producing, manufacturing, remanufacturing, propagating, or assembling an in vitro clinical test; (B) importing an in vitro clinical test; (C) modifying an in vitro clinical test initially developed by a different person in a manner that— (i) changes any of the listing elements that define indications for use specified in paragraph (10), performance claims, or, as applicable, the safety of such in vitro clinical test; or (ii) affects the analytical or clinical validity of the in vitro clinical test as intended by the developer