502
Opinion of Stevens, J.
tions and zoning codes, or to use due care in the training and supervision of a work force. These state requirements therefore escape pre-emption, not because the source of the duty is a judge-made common-law rule, but rather because their generality leaves them outside the category of requirements that § 360k envisioned to be "with respect to" specific devices such as pacemakers. As a result, none of the Lohrs' claims based on allegedly defective manufacturing or labeling are pre-empted by the MDA.
VI
In their cross-petition, the Lohrs present a final argument, suggesting that common-law duties are never "requirements" within the meaning of § 360k and that the statute therefore never pre-empts common-law actions. The Lohrs point out that our holding in Cipollone is not dispositive of this issue, for as Part IV, supra, suggests, there are signifi-cant textual and historical differences between the Cipollone statute and § 360k, and the meaning of words must always be informed by the environment within which they are situated. We do not think that the issue is resolved by the FDA regulation suggesting that § 360k is applicable to those requirements "having the force and effect of law" that are "established by . . . court decision," 21 CFR § 808.1(b) (1995); that reference, it appears, was intended to refer to court decisions construing state statutes or regulations. See 42 Fed. Reg. 30383, 30385 (1977); Brief for Petitioners in No. 95-886, p. 26, n. 7.
Nevertheless, we do not respond directly to this argument
for two reasons. First, since none of the Lohrs' claims is pre-empted in this suit, we need not resolve hypothetical cases that may arise in the future. Second, given the critical importance of device specificity in our (and the FDA's) construction of § 360k, it is apparent that few, if any, common-law duties have been pre-empted by this statute. It will be rare indeed for a court hearing a common-law
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