vitro clinical test does not add a manufacturing site, or change activities at an existing manufacturing site, with respect to the test, the holder of an approved application may, without submission of a supplemental application, implement the following modifications to the test: (i) Modifications in accordance with an approved change protocol under subsection (a)(3)(H). (ii) Modifications that are exempt under section 587C(a)(6). (iii) Labeling changes that are appropriate to address a safety concern, except such labeling changes that include any of the following remain subject to subparagraph (A): (I) A change to the indications for use of the test. (II) A change to the performance claims made with respect to the test. (III) A change that adversely affects performance of the test. (D) Reporting for certain modifications made pursuant to a change protocol The holder of an application approved under subsection (e), with an approved change protocol under subsection (a)(2)(H) for such in vitro clinical test shall— (i) report any modification to such test made pursuant to such change protocol approved under subsection (a)(3)(H) in a submission under section 587J(c)(2)(B)