; and (iii) falls within a category of tests that was exempt from the requirements for submission of a report under section 510(k) as of such date of enactment (including class II devices and excluding class I devices described in section 510(l)). (2) 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 paragraph (2), any special control that applied to a device within a predecessor category immediately prior to the date of enactment of Verifying Accurate Leading-edge IVCT Development Act of 2020 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587E to an in vitro clinical test within the successor category, except to the extent such mitigating measure is withdrawn or changed in accordance with section 587E. (3) Near-patient testing Not later than 1 year after the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 , the Secretary shall issue draft guidance indicating categories of tests that shall be exempt from premarket review under section 587B when offered for near-patient testing (point of care), which were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). (e) Low-Risk tests (1) Exemption An in vitro clinical test is exempt from premarket review under section 587B and may be lawfully marketed subject to the other applicable requirements of this Act, including section 587I(b)(6), if such test meets the definition of low-risk under section 587. (2) List of low-risk tests (A) In general The Secretary shall maintain, and make publicly available on the website of the Food and Drug Administration, a list of in vitro clinical tests, and categories of in vitro clinical tests, that are low-risk in vitro clinical tests for purposes of the exemption under this subsection. (B) Inclusion