; (B) performs, documents, and maintains a risk assessment (as described in subsection (a)(3)(B)(iii)) of the new instrument compared to the instrument approved under subsection (b) and no new risks are identified; (C) performs, documents, and maintains validation and verification activities for the new instrument; (D) makes such documentation available to the Secretary upon request; and (E) registers and lists the new instrument in accordance with section 587J. (2) Test kits and test protocols With regard to a test kit or test protocol that is approved under this section for use on an approved instrument or an instrument exempt from premarket review, including an instrument within an instrument family under this section, a submission under this section shall not be required for such test kit or test protocol in order for it to be used on a new instrument within its instrument family, provided that— (A) use of the test kit or test protocol with the new instrument does not— (i) change the claims for the test kit or test protocol, except as applicable, claims regarding an instrument or instruments that can be used with such test kit or test protocol; (ii) adversely affect performance of the test kit or test protocol; or (iii) cause the test kit or test protocol to no longer conform with performance standards required under section 587R or comply with any applicable mitigating measures under section 587E, conditions of approval under subsection (e)(2)(B), or restrictions under section 587O; (B) the test developer does not identify any new risks for the test kit or test protocol when using the new instrument after conducting a risk assessment; (C) the test developer validates the use of the new instrument with the test kit or test protocol and maintains validation documentation; (D) the test kit or test protocol is not intended for use— (i) in settings for which a certificate of waiver is in effect under section 353 of the Public Health Service Act; (ii) without a prescription; (iii) at home