; and (2) not later than 70 calendar days after the developer or other responsible party notifies the Secretary that it has completed a recall action, the Secretary shall provide the developer or other responsible party with a written statement closing the recall action or stating the reasons the Secretary cannot close the recall at that time. 587O. Restricted in vitro clinical tests (a) Applicability (1) In general For the types of in vitro clinical tests described in paragraph (3), the Secretary may require, in issuing an approval of an in vitro clinical test under section 587B, granting a technology certification order under section 587D, or in issuing a determination under section 587F(a), or by issuing a regulation, that such test, or category of tests, be restricted to sale, distribution, or use upon such conditions as the Secretary may prescribe under paragraph (2). (2) Conditions The Secretary may prescribe conditions under this section, based on available evidence, with respect to an in vitro clinical test described in paragraph (3), that are determined to be needed due to the potential for harmful effect of such test (including any resulting absence, significant delay, or discontinuation of appropriate medical treatment), and are necessary to ensure that the test meets the applicable standard. (3) In vitro clinical tests subject to restrictions The restrictions or conditions authorized under this section may be applied by the Secretary to any high-risk or moderate-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 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 an approval under section 587B, an order under section 587D, a determination under section 587F(a), or in regulation,