Cite as: 518 U. S. 470 (1996)
Opinion of the Court
cal to, requirements imposed by or under the act." 21 CFR § 808.1(d)(2) (1995); see also § 808.5(b)(1)(i).16 At this early
stage in the litigation, there was no reason for the Court of Appeals to preclude altogether the Lohrs' manufacturing and labeling claims to the extent that they rest on claims that Medtronic negligently failed to comply with duties "equal to, or substantially identical to, requirements imposed" under federal law.
Manufacturing and Labeling Claims
Finally, the Lohrs suggest that with respect to the manufacturing and labeling claims, the Court of Appeals should have rejected Medtronic's pre-emption defense in full. The Court of Appeals believed that these claims would interfere with the consistent application of general federal regulations governing the labeling and manufacture of all medical devices, and therefore concluded that the claims were preempted altogether.
The requirements identified by the Court of Appeals include labeling regulations that require manufacturers of every medical device, with a few limited exceptions, to include with the device a label containing "information for use, . . . and any relevant hazards, contraindications, side effects, and precautions." 21 CFR §§ 801.109(b) and (c) (1995). Similarly, manufacturers are required to comply with "Good Manufacturing Practices," or "GMP's," which are set forth in 32 sections and less than 10 pages in the Code of Federal Regulations.17 In certain circumstances, the Court of Ap-16 We also note that the agency permits manufacturers of devices that have received PMA to make certain labeling, quality control, and manufacturing changes which would "enhanc[e] the safety of the device or the safety in the use of the device" without prior FDA approval. See 21 CFR §§ 814.39(d)(1) and (2) (1995).
17 Some GMP's include the duty to institute a "quality assurance program," § 820.5, to have an "adequate organizational structure," § 820.20, to ensure that personnel in contact with a device are "clean, healthy, and suitably attired" where such matters are relevant to the device's safety,
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