; (ii) in the case of an in vitro clinical test made available to investigators for clinical testing, assurance that all investigators will comply with this section, regulations promulgated or revised under this section, and applicable human subjects regulations; and (iii) submit an assurance to the Secretary that informed consent will be obtained from each human subject (or the representative of such subject) of proposed clinical testing involving such in vitro clinical test, except in the case that— (I) there is a life-threatening situation involving the human subject of such testing which necessitates the use of such in vitro clinical test; (II) it is not feasible to obtain informed consent from the subject; and (III) there is not sufficient time to obtain such consent from a representative of such subject. (B) Exception The informed consent of human subjects shall not be required with respect to clinical testing conducted as part of an investigation, if— (i) the clinical testing uses remnants of specimens collected for routine clinical care or analysis that would have been discarded, leftover specimens that were previously collected for other research purposes, or specimens obtained from specimen repositories; (ii) the identity of the subject of the specimen is not known to, and may not readily be ascertained by, the investigator or any other individual associated with the investigation, including the sponsor; (iii) any clinical information that accompanies the specimens does not make the specimen source identifiable to the investigator or any other individual associated with the investigation, including the sponsor; (iv) the individuals caring for the human subjects as patients are different from, and do not share information about the patient with, the individuals conducting the investigation