Cite as: 518 U. S. 470 (1996)
Opinion of Stevens, J.
Lohrs' alleged injuries.9 Given the ambiguities in the statute and the scope of the preclusion that would occur otherwise, we cannot accept Medtronic's argument that by using the term "requirement," Congress clearly signaled its intent to deprive States of any role in protecting consumers from the dangers inherent in many medical devices.
Other differences between this statute and the one in Cipollone further convince us that when Congress enacted § 360k, it was primarily concerned with the problem of specific, conflicting state statutes and regulations rather than the general duties enforced by common-law actions. Unlike the statute at issue in Cipollone, § 360k refers to "requirements" many times throughout its text. In each instance, the word is linked with language suggesting that its focus is device-specific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries. For instance, subsections (a)(2) and (b) of the statute 10 also refer to "requirements"— but those "requirements" refer only to statutory and regulatory law that exists pursuant to the MDA itself, suggesting that the pre-empted "requirements" established or continued by States also refer primarily to positive enactments of state law. Moreover, in subsection (b) the FDA is given authority to exclude certain "requirements" from the scope of the preemption statute. Of the limited number of "exemptions"
9 Unlike § 360k, the pre-emptive effect of the statute in Cipollone was not dependent on the issuance of any agency regulations. The territory exclusively occupied by federal law was defined in the text of the statute itself; that text specified the precise warning to smokers that Congress deemed both necessary and sufficient. In the MDA, no such specifics exist until the FDA provides them. See also infra, at 495-496 (reliance on the FDA's interpretation of § 360k warranted, inter alia, because of the FDA's role in the administration of § 360k). Moreover, the statute in Cipollone was clearly intended to have a broader pre-emptive effect than its 1965 predecessor. See 505 U. S., at 515, 520-521.
10 The text of the statute is quoted supra, at 482, and n. 5.
489
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