; (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; and (xvi) statistical techniques. (2) Quality requirements for laboratories certified to conduct high-complexity tests Quality requirements applicable to the in vitro clinical tests and developers described in subsection (a)(2) shall— (A) avoid duplication of regulations under section 353 of the Public Health Service Act; 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