; (3) apply to the testing of patients if the State certifies that the test can be validated, as determined by the State; and (4) apply to laboratory-developed tests performed by laboratories and hospitals certified under section 353 of the Public Health Service Act ( 42 U.S.C. 263a ), and to such tests performed by clinical laboratory companies. (c) Suspension enforcement by FDA (1) In general Except as provided in paragraph (1), with respect to a diagnostic test or diagnostic device approved or cleared by a State pursuant to subsection (a), the Secretary may not, for the duration of the applicable public health emergency engage in any enforcement action— (A) with respect to the test or device, to the extent that such test or device is distributed and used within the State granting the approval or clearance in accordance with the requirements of the State; (B) against a State or State entity that clears or approves the test or device in accordance with this section; or (C) against any State, entity of a State, health care provider, health care facility, laboratory, educational institution, manufacturer, or distributor that prepares, propagates, compounds, assembles, or processes a diagnostic test or diagnostic device by chemical, physical, biological, or other procedure for such test or device or develops, manufactures, distributes, sells, administers, or evaluates such test— (i) within the applicable State in accordance with the requirements of the State