; (B) does not have an approval under section 515, a clearance under section 510(k), an authorization under section 513(f)(2), an approval under section 520(m), or an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360e , 360(k), 360c(f)(2), 360j(m), 360bbb–3) or approval under the Public Health Service Act ( 42 U.S.C. 201 et seq.)