; 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; (iii) the test meets the applicable standard as described in section 587(2); (iv) the labeling and advertising are not false or misleading; and (v) the test is not likely to cause or contribute to serious adverse health consequences. (B) Certain modifications A modification to extend specimen stability is exempt from premarket review under section 587B if the modified test meets the requirements in clauses (ii) through (v) of subparagraph (A). (C) Modifications under a change protocol Notwithstanding subparagraph (A), a modification made under a change protocol pursuant to subsection (a)(2)(H) of section 587B is exempt from review under such section. (D) Documentation A person who modifies an in vitro clinical test in a manner that is a modification described in this paragraph shall— (i) document the modification that was made and the basis for determining that the modification, considering the changes individually and collectively, is a type of modification described in subparagraph (A), (B), or (C)