; and (B) any in vitro clinical test (as so defined) that was cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ) or authorized under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(f)(2) ) is deemed to be approved pursuant to an application under section 587B(b) of the Federal Food, Drug, and Cosmetic Act, as added by this Act. (2) Deemed investigational use exemption Any in vitro clinical test that has an investigational device exemption in effect under section 520(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(g) ) is deemed to have an investigational use exemption in effect under section 587S of such Act, as added by this Act, beginning on the effective date of this Act. (3) Deemed humanitarian device exemption Any in vitro clinical test that has an approved humanitarian device exemption under section 520(m) of such Act is deemed to have a humanitarian test exemption under section 587A(g) of such Act, as added by this Act, beginning on the effective date of this Act. (4) Deemed designated breakthrough Any in vitro clinical test that has received a breakthrough device designation under section 515B(e)(1)(D) of such Act ( 21 U.S.C. 360e–3(e)(1)(D) ) is deemed to have a breakthrough in vitro clinical test designation under section 587C of such Act, as added by this Act, beginning on the effective date of this Act. (5) Deemed request for informal feedback With regard to any in vitro clinical test that is the subject of a pre-submission request described in the guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q–Submission Program , issued by the Food and Drug Administration on January 6, 2021, such request is deemed to constitute a request for informal feedback under section 587F of the Federal Food, Drug, and Cosmetic Act, as added by section 3, beginning on the effective date of this Act. (e) Previously classified devices Notwithstanding section 587 of the Federal Food, Drug, and Cosmetic