; and (ii) that such change does not expand the scope of the technology certification unless the Secretary deems appropriate. A supplement may contain only information relevant to the change or changes. The Secretary’s action on a supplement shall be in accordance with subsection (f), and any order resulting from such supplement shall be treated as an amendment to a technology certification order that is in effect. (B) Reports (i) In general If a change described in subparagraph (A) is made in order to address a potential risk to public health by adding a new specification or test method, the person may immediately implement such change or changes and shall report such changes or changes to the Secretary within 30 days. (ii) Content Any report to the Secretary under this subparagraph shall include— (I) a summary of the relevant change or changes; (II) the rationale for implementing such change or changes; and (III) a description of how the change or changes were evaluated. (iii) Supplemental reports Upon review of such report and a finding that the relevant change or changes are inconsistent with the standard specified under this subparagraph, the Secretary may require a supplement under subparagraph (A). (h) Maintenance requirements For the duration of a technology certification order, a holder of a technology certification order shall— (1) use the procedures included in the relevant application, supplement, or report under subsections (b) and (e); (2) ensure compliance with any applicable mitigating measures; (3) maintain, and provide to the Secretary upon request, records related to any in vitro clinical test offered without premarket review under the technology certification order, where those records are necessary to demonstrate compliance with applicable provisions of this subchapter