; exempt from premarket review A developer submitting a request that the Secretary make a determination as described in paragraph (1)(C) shall submit information that the in vitro clinical test is low-risk, or otherwise appropriate for exemption from premarket review under section 587B and propose mitigating measures, if applicable, that would support such a determination. (B) Response by the Secretary Not later than 30 days after receiving a request under clause (i) or (ii) of subparagraph (A), the Secretary shall provide a timely response describing whether or not the Secretary will initiate the process for making a determination under paragraph (1)(B) or (1)(C) as described in paragraph (4). (3) Sufficiency of mitigating measures When determining whether mitigating measures for an in vitro clinical test, or category of in vitro clinical tests, are sufficient to make such test moderate-risk or low-risk, the Secretary shall take into account the following: (A) The degree to which the technology for the intended use of the in vitro clinical test is well-characterized, taking into consideration factors that include one or more of the following: (i) Peer-reviewed literature. (ii) Practice guidelines. (iii) Consensus standards. (iv) Recognized standards of care. (v) Use of such technology, including historical use. (vi) Multiple scientific publications by different authors. (vii) Adoption by the scientific or clinical community. (viii) Real world evidence. (B) Whether the criteria for performance of the test are well-established to be sufficient for the intended use. (C) The clinical circumstances under which the in vitro clinical test is used, including whether the in vitro clinical test is the sole determinate for the diagnosis or treatment of the targeted disease, and the availability of other tests (such as confirmatory or adjunctive tests) or relevant material standards. (D) Whether such mitigating measures sufficiently mitigate the risk of harm such that the test or category of tests is moderate-risk or