; or (ii) any other information that the Secretary determines, if published, could compromise national security. (2) Order of temporary suspension If, after providing due notice and an opportunity for an informal hearing to the holder of an approved application for an in vitro clinical test under this section, the Secretary determines, based on scientific evidence, that there is a reasonable likelihood that the in vitro clinical test would cause death or serious adverse health consequences, such as by causing the absence, significant delay, or discontinuation of life-saving or life-sustaining medical treatment, the Secretary shall, by order, temporarily suspend the approval of the application. If the Secretary issues such an order, the Secretary shall proceed expeditiously under paragraph (1) to withdraw approval of such application. (3) Appeal withdrawing approval and orders of temporary suspensions An order of withdrawal or an order of temporary suspension may be appealed under 587P. 587C. Exemptions (a) In general The following in vitro clinical tests are exempt from premarket review under section 587B, and may be lawfully offered subject to other applicable requirements of this Act: (1) Tests exempt from section 510(k) (A) Exemption An in vitro clinical test is exempt from premarket review under section 587B and may be lawfully offered subject to the other applicable requirements of this Act, if the developer of the in vitro clinical test— (i) maintains documentation demonstrating that the test meets and continues to meet the criteria set forth in subparagraph (B); and (ii) makes such documentation available to the Secretary upon request. (B) Criteria for exemption An in vitro clinical test is exempt as specified in subparagraph (A) if such test— (i) (I) (aa) was offered for clinical use prior to the date of enactment of the VALID Act of 2023