; and (B) consist of, as directed related to the design and development— (i) design controls; (ii) purchasing controls; (iii) acceptance activities; (iv) corrective and preventative action; and (v) records. (3) Quality requirements for certain laboratories distributing in vitro clinical tests or test protocols within organizations or public health networks (A) In general Quality requirements applicable to the developer who is distributing in vitro clinical test distributed as described in subparagraph (B) shall consist of the following: (i) The requirements in paragraph (2). (ii) The labeling requirements in paragraph (1)(C)(xii). (iii) The requirement to maintain records of the laboratories to which the in vitro clinical test or test protocol is distributed. (B) Distributing laboratory Subparagraph (A) shall apply to developers that meet the following conditions: (i) The laboratory distributing the test protocol is certified by the Secretary under section 353 of the Public Health Service Act and meets the requirements for performing high-complexity testing. (ii) The laboratory develops its own in vitro clinical test or modifies another developer’s in vitro clinical test in a manner described in section 587(6). (iii) The laboratory distributes the in vitro clinical test or test protocol for such test only to another laboratory that— (I) is certified by the Secretary under section 353 of the Public Health Service Act and meets the requirements for performing high-complexity testing; (II) is within the same corporate organization and having common ownership by the same parent corporation; or as applicable, is a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention