; and (ii) makes such documentation available to the Secretary upon request. (B) Criteria for exemption An in vitro clinical test is exempt as specified in subparagraph (A) if— (i) the in vitro clinical test meets the applicable standard as described in 587(2); (ii) the labeling and advertising are not false or misleading; (iii) the in vitro clinical test is not likely to cause or contribute to serious adverse health consequences; and (iv) the in vitro clinical test falls within a category of tests listed as described in subparagraph (C). (C) List of low-risk tests (i) In general The Secretary shall maintain, and make publicly available on the website of the Food and Drug Administration, a list of in vitro clinical tests, and categories of in vitro clinical tests, that are low-risk in vitro clinical tests for purposes of the exemption under this paragraph. (ii) Inclusion The list under clause (i) shall consist of— (I) all in vitro clinical tests and categories of in vitro clinical tests that are exempt from premarket review pursuant to paragraph (1) or this paragraph; and (II) all in vitro clinical tests and categories of in vitro clinical tests that are designated by the Secretary pursuant to subparagraph (D) as low-risk for purposes of this paragraph. (D) Designation of tests and categories Without regard to subchapter II of chapter 5 of title 5, United States Code, the Secretary may designate, in addition to the tests and categories described in subparagraph (C)(i), additional in vitro clinical tests, and categories of in vitro clinical tests, as low-risk in vitro clinical tests for purposes of the exemption under this paragraph. The Secretary may make such a designation on the Secretary’s own initiative or in response to a request by a developer pursuant to subsection (a) or (b) of section 587F. In making such a designation for a test or category of tests, the Secretary shall consider— (i) whether the test, or category of tests, is low-risk