; (II) the intended use of the test unless provided under an approved change protocol under subsection (c)(2)(I); or (III) the safety of the specimen receptacles. (iii) Labeling changes to address a safety concern. (iv) Modifications that are exempt under section 587A(l). (D) Reporting for change protocol modifications As a component of the report required under subsection (k), the holder of an application approved under subsection (g) for an in vitro clinical test shall— (i) report any modification to the test described in clause (i) or (ii) of subparagraph (B) in the next annual report for the test under subsection (k) following the date on which the test, with such modification, is introduced into interstate commerce; and (ii) include in such report— (I) a description of the modification; and (II) as applicable, a summary of the analytical validity and clinical validity of the test, as modified, and any changes to acceptance criteria. (E) Reporting for other category of exceptions The holder of the application approved under subsection (c) or (d) for an in vitro clinical test shall— (i) report to the Secretary any modification to the test described in clause (iii) of subparagraph (C) not more than 60 days after the date on which the test, with the modification, is introduced into interstate commerce; and (ii) include in the report— (I) a summary of the relevant change or changes; (II) the rationale for implementing such change or changes