; or (ii) the investigator conducting or supervising the clinical testing determines in writing that there exists a life-threatening situation involving the human subject of such testing which necessitates the use of such in vitro clinical test and it is not feasible to obtain informed consent from the subject and there is not sufficient time to obtain such consent from a representative of such subject. (7) Concurred by licensed physician The determination required by paragraph (6)(C)(ii) shall be concurred in writing by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the in vitro clinical test is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence. (8) Significant risk For purposes of this subsection, the term significant risk means, with respect to an in vitro clinical test, that the use of such in vitro clinical test— (A) is of substantial importance in performing an activity or activities described in section 201(ss)(1) for, a serious or life-threatening disease or condition without confirmation of the diagnosis by a medically established diagnostic product or procedure; (B) requires an invasive sampling procedure that presents a significant risk to the human subject, provided that routine venipuncture shall not be considered an invasive sampling procedure