; (ii) the existence of and ability to develop mitigating measures sufficient for such test category to meet the low-risk standard; and (iii) such other factors as the Secretary determines to be appropriate for the protection of the public health. (3) Humanitarian test exemption (A) In general An in vitro clinical test that meets the criteria under subparagraph (B) is exempt from premarket review under section 587B and may be lawfully offered subject to the other applicable requirements of this subchapter, if the developer of the test— (i) maintains documentation (which may include literature citations in specialized medical journals, textbooks, specialized medical society proceedings, and governmental statistics publications, or, if no such studies or literature citations exist, credible conclusions from appropriate research or surveys) demonstrating that such test meets and continues to meet the criteria described in this subsection; and (ii) makes such documentation available to the Secretary upon request. (B) Criteria for exemption An in vitro clinical test is exempt as described in subparagraph (A) if— (i) the in vitro clinical test is intended by the developer for use for a diagnostic purpose for— (I) a noncontagious disease or condition that affects not more than 10,000 (or such other higher number determined by the Secretary) individuals in the United States per year; or (II) a contagious disease or condition that affects not more than 1,500 individuals in the United States per year; (ii) the in vitro clinical test meets the applicable standard described in section 587(2); (iii) the labeling and advertising for the in vitro clinical test are not false or misleading; (iv) the in vitro clinical test is not likely to cause or contribute to serious adverse health consequences