; (ii) was developed by a clinical laboratory for which a certificate is in effect under section 353 of the Public Health Service Act that meets the requirements under section 353 for performing high-complexity testing; and (iii) is performed— (I) in the same clinical laboratory in which it was developed; (II) by another clinical laboratory for which a certificate is in effect under section 353 within the same corporate organization and having common ownership by the same parent corporation; or (III) by a laboratory within a public health laboratory network coordinated or managed by the Centers for Disease Control and Prevention; (B) does not have in effect an approval under section 515, a clearance under section 510(k), an authorization under section 513(f)(2), or an approval under section 520(m); and (C) is not modified on or after the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 by its initial developer (or another person) in a manner such that the test is a new in vitro clinical test under subsection (l). (3) Modifications In the case of a modification to an vitro clinical test that is exempt as specified in paragraph (1) or determines that such modification is otherwise not subject to premarket review pursuant to section 587A(l), the test continues to qualify for such exemption if the person modifying such test— (A) documents each such modification and maintains a summary of the basis for such determination; and (B) provides such documentation and summary to the Secretary upon request or inspection. (d) Tests exempt from section 510( k ) (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, if the in vitro clinical test— (A) (i) was offered for clinical use prior to the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020