; (B) was a laboratory, or an owner or operator or any employee of a laboratory, found to have committed a significant violation of section 353 of the Public Health Service Act that resulted in a suspended, revoked, or limited certificate within the 2-year period preceding the date of the submission of the application for a technology certificate under subsection (c) and such violation has not been resolved; or (C) has been found to have submitted information to the Secretary, or otherwise disseminated information, that— (i) made false or misleading statements relevant to the requirements of this subchapter; or (ii) violated any requirement of this Act, where such violation exposed individuals to serious risk of illness, injury, or death, unless— (I) such violation has been resolved; or (II) such violation is not pertinent to any in vitro clinical test within the scope of the technology certification that such developer seeks. (b) Applicability (1) In general An in vitro clinical test is not subject to section 587B and may be introduced into interstate commerce if the in vitro clinical test— (A) is an eligible in vitro clinical test; (B) is developed by an eligible person; (C) falls within the scope of a technology certification order issued under this section and that is in effect; (D) complies with the conditions of the technology certification order, including with applicable mitigating measures under section 587E, restrictions under section 587O, and performance standards under section 587R