Cite as: 518 U. S. 470 (1996)
Opinion of the Court
facturer of a medical device. See Duncan v. Iolab Corp., 12 F. 3d 194 (1994). After reconsidering its ruling in light of Duncan, the District Court reversed its earlier decision and dismissed the Lohrs' entire complaint.
The Court of Appeals reversed in part and affirmed in part. 56 F. 3d 1335 (CA11 1995). Rejecting the Lohrs' broadest submission, it first decided that "common law actions are state requirements within the meaning of § 360k(a)." Id., at 1342. It next held that pre-emption could not be avoided by merely alleging that the negligence flowed from a violation of federal standards. Id., at 1343. Then, after concluding that the term "requirements" in § 360k(a) was unclear, it sought guidance from FDA's regulations regarding pre-emption. Those regulations provide that a state requirement is not pre-empted unless the FDA has established " 'specific requirements applicable to a particular device.' " Id., at 1344 (citing 21 CFR § 808.1(d) (1995)). Under these regulations, the court concluded, it was not necessary that the federal regulation specifically deal with pacemakers, but only that the federal requirement "should, in some way, be 'restricted by nature' to a particular process, procedure, or device and should not be completely open-ended," 56 F. 3d, at 1346 (footnote omitted), and that the specific device at issue should be subject to its requirements.
Under this approach, the court concluded that the Lohrs' negligent design claims were not pre-empted. It rejected Medtronic's argument that the FDA's finding of "substantial equivalence" had any significance with respect to the pacemaker's safety, or that the FDA's continued surveillance of the device constituted a federal "requirement" that its design be maintained. Id., at 1347-1349. On the other hand, it concluded that the negligent manufacturing and failure to warn claims were pre-empted by FDA's general "good manufacturing practices" regulations, which establish general requirements for most steps in every device's manufacture, see id., at 1350; 21 CFR §§ 820.20-820.198 (1995), and by the
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