514
Opinion of O'Connor, J.
including a manufacturer's organization and personnel, buildings, equipment, component controls, production and process controls, packaging and labeling controls, holding, distribution, installation, device evaluation, and recordkeeping. See 21 CFR §§ 820.20-820.198 (1995). The Lohrs' common-law claims regarding manufacture would, if successful, impose state requirements "different from, or in addition to," the GMP requirements, and are therefore pre-empted. In similar fashion, the Lohrs' failure to warn claim is pre-empted by the extensive labeling requirements imposed by the FDA. See, e. g., 21 CFR § 801.109 (1995) (requiring labels to include such information as indications, effects, routes, methods, frequency and duration of administration, relevant hazards, contraindications, side effects, and precautions). These extensive federal manufacturing and labeling requirements are certainly applicable to the device manufactured by Medtronic. Section 360k(a) requires no more specificity than that for pre-emption of state common-law claims.
To summarize, I conclude that § 360k(a)'s term "requirement" encompasses state common-law claims. Because the statutory language does not indicate that a "requirement" must be "specific," either to pre-empt or be pre-empted, I conclude that a state common-law claim is pre-empted if it would impose "any requirement" "which is different from, or in addition to," any requirement applicable to the device under the FDCA. I would affirm the judgment of the Court of Appeals that the Lohrs' design claim is not pre-empted by the MDA, and that the manufacture and failure to warn claims are pre-empted; I would reverse the judgment of the Court of Appeals that the MDA pre-empts a common-law claim alleging violation of federal requirements.
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