finally
(ii)The term “covered remedy” means an outcome— (I)that is a criminal conviction, an injunction, or a condemnation, a civil monetary payment, a product recall, a repair or replacement of a product, a termination of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)], a debarment, an investigator disqualification, a revocation of an authorization under section 564 of such Act [21 U.S.C. 360bbb–3], or a suspension or withdrawal of an approval or clearance under chapter 5 1of such Act or of a licensure undersection 262 of this title; and (II)that results from a final determination by a court or from a final agency action. (iii)The terms “final” and “finally”— (I)with respect to a court determination, or to a final resolution of an enforcement action that is a court determination, mean a judgment from which an appeal of right cannot be taken or a voluntary or stipulated dismissal; and (II)with respect to an agency action, or to a final resolution of an enforcement action that is an agency action, mean an order that is not subject to further review within the agency and that has not been reversed, vacated, enjoined, or otherwise nullified by a final court determination or a voluntary or stipulated dismissal. (C) (i)Nothing in this paragraph shall be construed— (I)to affect the interpretation of any provision of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301et seq.], of this chapter, or of any other applicable statute or regulation; or (II)to impair, delay, alter, or affect the authority, including the enforcement discretion, of the United States, of the Secretary, of the Attorney General, or of any other official with respect to any administrative or court proceeding under this chapter, under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301et seq.], under title 18, or under any other applicable statute or regulation. (ii)A mandatory recall called for in the declaration is not a Food and Drug Administration enforcement action. (d)