Secretary provides the sponsor of the in vitro clinical test with an opportunity for an informal hearing. (B) Exception An order referred to in subparagraph (A) with respect to an investigational use exemption granted under this section may be issued on a preliminary basis before the provision of an opportunity for an informal hearing if the Secretary determines that the continuation of testing under the exemption will result in an unreasonable risk to the public health. The Secretary will provide an opportunity for an informal hearing promptly following any preliminary action under this subparagraph. (f) Changes (1) In general The regulations promulgated under subsection (b) shall provide, with respect to an in vitro clinical test for which an exemption under this subsection is in effect, procedures and conditions under which changes are allowed without the additional approval of an application for an exemption or submission of a supplement to such an application. Such regulations shall provide that such a change may be made if— (A) the sponsor determines, on the basis of credible information (as defined in regulations) that the change meets the conditions specified in paragraph (2)