; or (II) within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention, if the test is developed by a public health laboratory or the Centers for Disease Control and Prevention; and (C) does not manufacture, produce, or distribute in vitro clinical tests other than laboratory test protocols. (3) Regulations The Secretary shall promulgate quality system regulations implementing this section. In promulgating such regulations under this section, the Secretary shall consider whether, and to what extent, international harmonization is appropriate. (4) Quality systems for hybrid developers of both laboratory test protocols and other in vitro clinical tests An entity that develops both laboratory test protocols and other in vitro clinical tests shall comply with subsection (b)(1) for activities related to the development of any in vitro clinical test that is not a laboratory test protocol and with subsection (b)(2) or (b)(3), as applicable, for activities related to the development of any laboratory test protocol. (b) Quality requirements (1) In general The quality requirements applicable under this section shall— (A) avoid duplication of regulations and guidance under section 353 of the Public Health Service Act, such that laboratories would not be subject to conflicting regulatory obligations with respect to the same activity; (B) not apply to laboratory operations; and (C) include, as applicable, subject to subparagraphs (A) and (B) and paragraphs (2) and (3)— (i) management responsibilities; (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 in vitro clinical tests; (xi) corrective and preventive action; (xii) labeling and packaging controls; (xiii) handling, storage, distribution, and installation; (xiv) complaints and records; (xv) servicing