; or as applicable, is a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; and (III) implements the test protocol without further modification. (c) Regulations In implementing quality requirements for test developers under this section, the Secretary shall— (1) for purposes of facilitating international harmonization, consider whether the developer participates in an audit program in which the United States participates or the United States recognizes or conforms with standards recognized by the Secretary; and (2) ensure a least burdensome approach described in section 587B(j) by leveraging, to the extent applicable, the quality assurance requirements applicable to developers certified by the Secretary under section 353 of the Public Health Service Act. 587K. Labeling requirements (a) In General An in vitro clinical test shall bear or be accompanied by labeling, and a label as applicable, that meet the requirements set forth in subsections (b) and (c), unless such test is exempt as specified in subsection (d) or (e). (b) Labels (1) In general The label of an in vitro clinical test shall meet the requirements set forth in paragraph (2), except this requirement shall not apply to an in vitro clinical test that— (A) consists solely of a test protocol