; or (ii) is developed and used in laboratories for which a certificate is in effect under section 353 of the Public Health Service Act to conduct high-complexity testing and the developer— (I) is pursuing an emergency use authorization under section 564 and provides updates to the Secretary on efforts to pursue such authorization; (II) validates such in vitro clinical test prior to use; (III) notifies the Secretary of the assay validation; and (IV) includes a statement together with the results of the test that reads: This IVCT was developed for use as a part of a response to a public health emergency. This test has not been reviewed by the Food and Drug Administration. . (C) Disposition of product With respect to a previously unapproved in vitro clinical test or an in vitro clinical tests with an unapproved use, for which an emergency use authorization under section 564(b) ceases to be effective, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product. (D) Streamlining of application review A developer may include any data or information already submitted to the Secretary within the emergency use authorization as a part of a premarket application under section 587B or a technology certification application under section 587D. (b) Components and Parts (1) Exemption (A) In general Subject to subparagraph (B), a component, part, or raw material described in section 201(ss)(1)(F) is exempt from the requirements of this subchapter if it is— (i) intended for further development as described in paragraph (2)