Cite as: 518 U. S. 470 (1996)
Opinion of O'Connor, J.
do not impose requirements, "such an analysis is at odds both with the plain words" of the statute and "with the general understanding of common-law damages actions." Ibid. If § 360k's language is given its ordinary meaning, it clearly pre-empts any state common-law action that would impose a requirement different from, or in addition to, that applicable under the FDCA—just as it would pre-empt a state statute or regulation that had that effect. Justice Breyer reaches the same conclusion. Ante, at 503-505 (opinion concurring in part and concurring in judgment).
The plurality's reasons for departing from this reading are neither clear nor persuasive. It fails to refute the applicability of the reasoning of Cipollone. Instead, in Part IV, the plurality essentially makes the case that the statute's language, purpose, and legislative history, as well as the consequences of a different interpretation, indicate that Congress did not intend "requirement" to include state common-law claims at all. The principal opinion proceeds to disclaim this position, however, in Parts V and VI and concludes, rather, that a state common-law action might constitute a requirement, but that such a case would be "rare indeed." Ante, at 502. The Court holds that an FDCA "requirement" triggers pre-emption only when a conflict exists between a specific state requirement and a specific FDCA requirement applicable to the particular device. See ante, at 498-502. But see ante, at 500 ("[W]e do not believe that this statutory and regulatory language necessarily precludes 'general' federal requirements from ever pre-empting state requirements, or 'general' state requirements from ever being pre-empted . . ."). The plurality emphasizes the "critical importance of device specificity" in its understanding of the pre-emption scheme. Ante, at 502.
To reach its particularized reading of the statute, the Court imports the interpretation put forth by the FDA's regulations. Justice Breyer similarly relies on the FDA regulations to arrive at an understanding of § 360(k). Ante,
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