; and (2) the term removal means the physical removal of an in vitro clinical test from its point of use to another location for repair, modification, adjustment, relabeling, destruction, or inspection, and does not include routine servicing. 587N. Restricted in vitro clinical tests (a) Applicability (1) In general The Secretary, in issuing an approval of an in vitro clinical test under section 587B of a category described in paragraph (3) may require that such test be restricted to sale, distribution, or use upon such conditions as the Secretary may prescribe under paragraph (2). (2) Conditions prescribed by the secretary The conditions prescribed by the Secretary under this paragraph, with respect to an in vitro clinical test described in paragraph (3), are those conditions which the Secretary determines due to the potentiality for harmful effect of such test (including any resulting absence, delay, or discontinuation of appropriate medical treatment), are necessary to assure the analytical or clinical validity of the test, or the safety of a specimen receptacle. (3) In vitro clinical tests subject to restrictions The restrictions authorized under this section may be applied by the Secretary to any high-risk in vitro clinical test, prescription home-use in vitro clinical test, direct-to-consumer in vitro clinical test, or over-the-counter in vitro clinical test. (b) Labeling and Advertising of a Restricted In Vitro Clinical Test The label, labeling, and advertising of an in vitro clinical test to which restrictions apply under subsection (a) shall bear such appropriate statements of the restrictions as the Secretary may prescribe in the approval, provisional approval, technology certification, or regulation, as applicable. (c) Requirements prior to enactment An in vitro clinical test that was offered, sold, or distributed as a restricted device prior to the enactment date of this subchapter shall continue to comply with the applicable restrictions imposed under section 515 or section 520(e) until the effective