; (iv) bench studies; (v) case studies or histories; (vi) clinical data; (vii) consensus standards; (viii) reference standards; (ix) data registries; (x) postmarket data; (xi) real world data; (xii) clinical trials; and (xiii) data collected in countries other than the United States if such data are demonstrated to be appropriate for the purpose of making a regulatory determination under this subchapter. 587A. Regulation of in vitro clinical tests (a) In general No person shall introduce or deliver for introduction into interstate commerce any in vitro clinical test, unless— (1) an approval of an application filed pursuant to subsection (a) or (b) of section 587B is effective with respect to such in vitro clinical test; (2) the in vitro clinical test is offered under a technology certification order under section 587D(b)(1); or (3) the test is exempt under sections 587C or 587G from the requirements of section 587B. (b) Transfer or sale of In vitro clinical tests (1) Transfer and assumption of regulatory obligations If ownership of an in vitro clinical test is sold or transferred in such manner that the developer transfers the regulatory submissions and obligations applicable under this subchapter with respect to the test, the transferee or purchaser becomes the developer of the test and shall have all regulatory obligations applicable to such a test under this subchapter. The transferee or purchaser shall update the registration and listing information under section 587J for the in vitro clinical test. (2) Transfer or sale of premarket approval (A) Notice required If a developer of an in vitro clinical test transfers or sells the approval of the in vitro clinical test, the transferor or seller shall— (i) submit a notice of the transfer or sale to the Secretary and update the registration and listing information under section 587J for the in vitro clinical test