; (B) (i) develops an vitro clinical test or indications for use; or (ii) modifies another developer’s in vitro clinical test in that certified laboratory in a manner described in section 587(6); and (C) develops an in vitro clinical test or indications for use that are for use only within that certified laboratory or within another certified laboratory with common ownership, shall establish and maintain quality requirements that comply with the requirements set forth in subsection (b)(2). (3) Applicability for certain in vitro clinical tests The applicable requirements set forth in subsection (b)(1) shall apply to any instrument, specimen receptacle, or component or part that is developed for use by a clinical laboratory to which paragraph (2) applies. (4) Regulations The Secretary may promulgate regulations to implement this section. In so promulgating regulations, the Secretary shall consider whether and to what extent international harmonization is appropriate. (b) Quality requirements (1) Quality requirements for laboratories without CLIA certification to conduct high-complexity tests The quality requirements applicable under this section shall— (A) avoid duplication of regulations under section 353 of the Public Health Service Act; (B) apply only to the development, validation, production, preparation, propagation, or assembly related to the design and associated manufacture and distribution of an in vitro clinical test offered under this subchapter; (C) not apply with respect to laboratory operations; and (D) shall include the following, subject to paragraphs (2) and (3)— (i) management responsibility; (ii) quality audits; (iii) personnel; (iv) design controls; (v) document controls; (vi) purchasing controls; (vii) identification and traceability; (viii) production and process controls; (ix) acceptance activities; (x) nonconforming product; (xi) corrective and preventive action; (xii) labeling and packaging controls; (xiii) handling, storage, distribution, and installation; (xiv) records; (xv) servicing