; and (iii) shall provide for notice to individuals subject to the risks associated with the use of such in vitro clinical test. In providing the notice required by this clause, the Secretary may use the assistance of health professionals who prescribed, ordered, or used such an in vitro clinical test for individuals. (4) Clarification The remedy provided by this subsection shall be in addition to remedies provided by subsections (a), (b), and (c). 587AA. Applicability (a) In general An in vitro clinical test shall be subject to the requirements of this subchapter, except as otherwise provided in this subchapter. Laboratory operations shall not be subject to the requirements of this subchapter. (b) Interstate commerce Any in vitro clinical test that is offered, including by making available for clinical use in the United States is deemed to be an act that constitutes introduction into interstate commerce for purposes of enforcing the requirements of this Act. (c) Least burdensome requirements (1) In general In carrying out this subchapter, the Secretary shall consider the least burdensome means necessary to meet the applicable standard, and other regulatory requirements, as determined by the Secretary. (2) Necessary defined For purposes of paragraph (1), the term necessary means the minimum required information that would support a determination by the Secretary that the application meet the applicable standard or regulatory requirement, as determined by the Secretary. (d) Service of orders Orders of the Secretary under this section with respect to applications under subsection (a) or (b) of section 587B or supplements under subsection (f) of such section shall be served— (1) in person by any officer or employee of the Department of Health and Human Services designated by the Secretary