; (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 adequate for the purpose of making a regulatory determination under the applicable standard in the United States. (20) Well-characterized The term well-characterized , with respect to an in vitro clinical test, means well-established and well-recognized by the scientific or clinical community, if adequately evidenced by one or more of the following: (A) Peer-reviewed literature. (B) Practice guidelines. (C) Consensus standards. (D) Recognized standards of care. (E) Technology in use for many years. (F) Scientific publication by multiple sites. (G) Adoption by the scientific or clinical community. (H) Real world data. 587A. Applicability (a) In general (1) Applicability of this subchapter (A) In general An in vitro clinical test shall be subject to the requirements of this subchapter, except as otherwise provided this subchapter. (B) Interstate commerce Any in vitro clinical test that is offered for clinical use in the United States is deemed to be introduced into interstate commerce for purposes of enforcing the requirements of this Act. (C) Non-applicable requirement Subject to any exemption or exclusion in this section, an in vitro clinical test shall not be subject to any provision or requirement of this Act other than this subchapter unless such other provision or requirement— (i) applies expressly to in vitro clinical tests; or (ii) describes the authority of the Secretary when regulating such in vitro clinical tests or subset of in vitro clinical tests, with respect to— (I) all articles regulated by the Secretary pursuant to this Act