; and (B) the developer of the test— (i) maintains documentation (which may include literature citations in specialized medical journals, textbooks, specialized medical society proceedings, 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 paragraph; and (ii) makes such documentation available to the Secretary upon request. (2) Cross-referenced tests In order to be eligible for an exemption under this subsection, the developer of a cross-referenced test shall submit a request under section 587H for informal feedback. (h) Custom tests and low-Volume tests An in vitro clinical test is exempt from premarket review under section 587B, the quality requirements under section 587J, and the notification requirements under section 587I, and may be lawfully marketed subject to the other applicable requirements of this Act, if— (1) such in vitro clinical test— (A) is a low-volume test performed in a laboratory in which it was developed or developed in a laboratory within the same corporate organization with the laboratory in which such test is performed and is administered to no more than 5 patients per year, unless otherwise determined by the Secretary; or (B) is a custom test developed or modified to diagnose a unique pathology or physical condition of a specific patient for which no other in vitro clinical test is commercially available in the United States, and is— (i) not intended for use with respect to other patients; and (ii) after the development of the custom test, not included in any test menu, template test report, or other promotional materials, and not otherwise advertised; and (2) the developer of the test— (A) maintains documentation demonstrating that such test meets and continues to meet the applicable criteria described in paragraph (1)