484
Opinion of the Court
FDA labeling regulations, which require devices to bear various warnings, see 56 F. 3d, at 1350-1351; 21 CFR § 801.109 (1995). The court made a parallel disposition of the strict-liability claims, holding that there was no pre-emption insofar as plaintiffs alleged an unreasonably dangerous design, but they could not revive the negligent manufacturing or failure to warn claims under a strict-liability theory. 56 F. 3d, at 1351-1352.
Medtronic filed a petition for certiorari seeking review of
the Court of Appeals' decision insofar as it affirmed the District Court and the Lohrs filed a cross-petition seeking review of the judgment insofar as it upheld the pre-emption defense. Because the Courts of Appeals are divided over the extent to which state common-law claims are pre-empted by the MDA,6 we granted both petitions. 516 U. S. 1087 (1996).
III
As in Cipollone v. Liggett Group, Inc., 505 U. S. 504 (1992), we are presented with the task of interpreting a statutory provision that expressly pre-empts state law. While the pre-emptive language of § 360k(a) means that we need not go beyond that language to determine whether Congress intended the MDA to pre-empt at least some state law, see id., at 517, we must nonetheless "identify the domain expressly pre-empted" by that language, ibid. Although our analysis of the scope of the pre-emption statute must begin with its text, see Gade v. National Solid Wastes Management Assn.,
6 See, e. g., English v. Mentor Corp., 67 F. 3d 477 (CA3 1995) (§ 510(k) process creates pre-emptive "requirements"); Feldt v. Mentor Corp., 61 F. 3d 431 (CA5 1995) (§ 510(k) process does not create pre-emptive "requirements"); Michael v. Shiley, Inc., 46 F. 3d 1316 (CA3 1995) (claim alleging violation of federal requirement not pre-empted); 56 F. 3d 1335 (CA11 1995) (case below) (claim alleging violation of federal requirement may be pre-empted; § 510(k) process may create pre-emptive requirements; common-law claims covered by § 360k(a)); Kennedy v. Collagen Corp., 67 F. 3d 1453 (CA9 1995) (common-law claims not covered at all by § 360k(a)).
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