Cite as: 518 U. S. 470 (1996)
Opinion of Breyer, J.
cause of action to issue a decree that has "the effect of establishing a substantive requirement for a specific device." 21 CFR § 808.1(d)(6)(ii) (1995). Until such a case arises, we see no need to determine whether the statute explicitly preempts such a claim. Even then, the issue may not need to be resolved if the claim would also be pre-empted under conflict pre-emption analysis, see Freightliner Corp. v. Myrick, 514 U. S. 280, 287 (1995).
VII
Accordingly, the judgment of the Court of Appeals is reversed insofar as it held that any of the claims were preempted and affirmed insofar as it rejected the pre-emption defense. The cases are remanded for further proceedings.
It is so ordered.
Justice Breyer, concurring in part and concurring in the judgment.
This action raises two questions. First, do the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act ever pre-empt a state-law tort action? Second, if so, does the MDA pre-empt the particular state-law tort claims at issue here?
I
My answer to the first question is that the MDA will sometimes pre-empt a state-law tort suit. I basically agree with Justice O'Connor's discussion of this point and with her conclusion. See post, at 510-512. The statute's language, read literally, supports that conclusion. It says:
"[N]o State . . . may establish . . . with respect to a device . . . any [state] requirement . . . which is different from, or in addition to, any [federal] requirement . . . ." 21 U. S. C. § 360k(a) (emphasis added).
503
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