; or (II) a clinical laboratory certified by the Secretary under section 353 of the Public Health Service Act that meets the requirements for performing high complexity testing, to a lawfully offered in vitro clinical test, including another developer’s lawfully offered in vitro clinical test, excluding investigational in vitro clinical tests offered under section 587S, and the modified test is performed— (aa) in the same clinical laboratory in which it was developed for which a certification is still in effect under section 353 that meets the requirements to perform tests of high complexity; (bb) by another clinical laboratory for which a certificate is in effect under section 353 that meets the requirements to perform tests of high complexity, is within the same corporate organization, and has common ownership by the same parent corporation as the laboratory in which the test was developed; or (cc) by a clinical laboratory for which a certificate is in effect under section 353 that meets the requirements to perform tests of high complexity and is within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, if the test was developed by the Centers for Disease Control and Prevention or another laboratory within such public health laboratory network; (ii) the modification does not— (I) constitute a significant change to the indications for use, except for changes to a specimen type, as specified in the guidance issued under subparagraph (E); (II) cause the test to no longer comply with applicable mitigating measures under section 587E or restrictions under section 587O; (III) significantly change performance claims or significantly and adversely change performance, unless provided for under an approved change protocol under section 587B(a)(3)(H); or (IV) constitute an adverse change in the safety of the in vitro clinical test for individuals who come in contact with the in vitro clinical test