; (B) such in vitro clinical tests, including a first-of-a-kind test, is moderate-risk and subject to abbreviated premarket review under section 587B(b) or technology certification under section 587D(a)(1); or (C) such in vitro clinical test, including a first-of-a-kind test is low-risk or otherwise exempt from premarket review under section 587B. (2) Requests (A) Submissions by developers (i) Abbreviated premarket review; technology certification A developer submitting a request that the Secretary make a determination as described in paragraph (1)(B) shall submit information to support that the in vitro clinical test is moderate-risk or propose mitigating measures, if applicable, that would support such a determination. (ii) Low-risk