496
Opinion of the Court
given the FDA a unique role in determining the scope of § 360k's pre-emptive effect. Unlike the statute construed in Cipollone, for instance, pre-emption under the MDA does not arise directly as a result of the enactment of the statute; rather, in most cases a state law will be pre-empted only to the extent that the FDA has promulgated a relevant federal "requirement." Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the Act,15 the agency is uniquely qualified to determine whether a particular form of state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress," Hines v. Davidowitz, 312 U. S. 52, 67 (1941), and, therefore, whether it should be pre-empted. For example, Congress explicitly delegated to the FDA the authority to exempt state regulations from the pre-emptive effect of the MDA—an authority that necessarily requires the FDA to assess the pre-emptive effect that the Act and its own regulations will have on state laws. See § 360k(b). FDA regulations implementing that grant of authority establish a process by which States or other individuals may request an advisory opinion from the FDA regarding whether a particular state requirement is pre-empted by the statute. See 21 CFR § 808.5 (1995). The ambiguity in the statute—and the congressional grant of authority to the agency on the matter contained within it—provide a "sound basis," post, at 509 (O'Connor, J., concurring in part and dissenting in part), for giving substantial weight to the agency's view of the statute. See Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837 (1984); Hillsborough Cty., 471 U. S., at 714 (considering FDA understanding of pre-emptive effect of its regulations "dispositive").
The regulations promulgated by the FDA expressly support the conclusion that § 360k "does not preempt State or local requirements that are equal to, or substantially identi-15 See n. 5, supra; 21 U. S. C. § 371(a).
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