Right to Test Act

To allow States to approve the use of diagnostic tests during a public health emergency. 1. Short title This Act may be cited as the Right to Test Act 2. State approval of diagnostic tests (a) In general Notwithstanding chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 42 U.S.C. 263a Secretary 42 U.S.C. 247d (b) Application An approval or clearance pursuant to subsection (a) may— (1) allow for the preparation, compounding, assembly, propagation, manufacture, development, sale, distribution, or use of a specified diagnostic test or diagnostic device to address the health diagnostic needs of the State during the public health emergency; (2) apply to a diagnostic test or diagnostic device needed to address the health diagnostic needs of the State during the public health emergency, as determined by the State, including, but not limited to, a test or device that uses reagents or swabbing (including self-swab); (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 (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; or (ii) for the applicable State or individuals or entities that are located within the applicable State. (2) Exception The provisions of paragraph (1) shall not apply with respect to a State if the Governor of the State requests that enforcement continue in the State during the public health emergency. (d) Action by FDA after public health emergency Not later than 180 days after the end of any public health emergency under which a State exercises its authority under subsection (a) with respect to a diagnostic test or diagnostic device, if the Food and Drug Administration has not cleared or approved such test or device under chapter V of the Federal Food, Drug, and Cosmetic Act, the Secretary shall review and make a final determination, within such 180-day period, with respect to such test or device for clearance or approval. (e) Diagnostic tests and diagnostic devices In this section, the terms diagnostic test diagnostic device

Summary: Right to Test Act This bill authorizes a state's public health department, or another entity designated by the state's governor, to approve a diagnostic test or diagnostic device (e.g., a test for the virus that causes COVID-19, or coronavirus disease 2019) for use during a public health emergency. Unless requested by the governor of the state, the Food and Drug Administration (FDA) may not, during the emergency, engage in certain enforcement actions related to such a test or device. Not later than 180 days following the end of the public health emergency, the FDA must review and make a final determination concerning approval of the test or device.