; (B) causes the test to no longer comply with applicable mitigating measures under section 587E or restrictions under section 587N; or (C) as applicable, affects the safety of an article for taking or deriving specimens from the human body for a purpose described in section 201(ss)(1). (2) Exemptions Notwithstanding paragraph (1), an in vitro clinical test that is modified by the initial developer of the test or a different person is not a new in vitro clinical test if the modification— (A) is a software update that does not have an adverse effect on the analytical or clinical validity or result in an increased risk to patients and consumers; (B) is made pursuant to methods or criteria included in the change protocol premarket submission, amendment, or supplement approved by the Secretary for the in vitro clinical test being modified; (C) is a labeling change that is appropriate to address patient or user harm; or (D) is a specimen-related modification that is made to extend specimen stability or aligns with the data and information submitted in an approved application for premarket review under section 587B or an order issued under section 587D. (3) Documentation When a person modifies an in vitro clinical test that was developed by another person, such modified test is exempt from the requirements of this subchapter provided that such person— (A) documents the modification that was made and the basis for determining that the modification, considering the changes individually and collectively, was not a type of modification described in paragraph (1)