; and (2) ensure a least burdensome approach described in section 587AA(c) 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. 587L. Labeling requirements (a) In general An in vitro clinical test shall bear or be accompanied by labeling, as applicable, that meets the requirements set forth in subsections (b) and (c), unless such test is exempt under 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) if there is an immediate container to which the label is applied. (2) Regulations The label of an in vitro clinical test shall state the name and place of business of its developer and meet the requirements set forth in regulations promulgated in accordance with this section. (c) Labeling (1) In general Labeling of an in vitro clinical test, including labeling in the form of a package insert, website, standalone laboratory reference document, or other similar document shall include— (A) adequate directions for use and shall meet the requirements set forth in regulations promulgated under this section, except as provided in subsection (d) or (e); and (B) the information described in paragraph (2), as applicable. (2) Content Labeling of an in vitro clinical test shall include— (A) the test listing number that was provided to the developer at the time of listing; (B) information to facilitate reporting an adverse event; (C) information regarding accessing the performance summary data displayed in the listing database for the test; (D) the indications for use of the in vitro clinical test