; (ii) meets the applicable standard as described in section 587(2); (iii) is not offered with labeling and advertising that is false or misleading; and (iv) is not likely to cause or contribute to serious adverse health consequences. (C) Effect on special controls For any in vitro clinical test, or category of in vitro clinical tests, that is exempt from premarket review based on the criteria in subparagraph (B), any special control that applied to a device within a predecessor category immediately prior to the date of enactment of the VALID Act of 2023 shall be deemed a mitigating measure applicable under section 587E to an in vitro clinical test within the successor category, except to the extent such mitigating measure is withdrawn or changed in accordance with section 587E. (D) Near-patient testing Not later than 1 year after the date of enactment of the VALID Act of 2023 , the Secretary shall issue draft guidance indicating categories of tests that shall be exempt from premarket review under section 587B when offered for near-patient testing (point of care), which were not exempt from submission of a report under section 510(k) pursuant to subsection (l) or (m)(2) of section 510 and regulations imposing limitations on exemption for in vitro devices intended for near-patient testing (point of care). (2) Low-risk tests (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, including section 587J(b), if such test meets the definition of low-risk under section 587 and if the developer of the test— (i) maintains documentation demonstrating that the in vitro clinical test meets and continues to meet the criteria set forth in subparagraph (B)