Cite as: 518 U. S. 470 (1996)
Opinion of the Court
ther note that the statute is not intended to pre-empt "State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices . . . or to unfair trade practices in which the requirements are not limited to devices." § 808.1(d)(1). The regulations specifically provide, as examples of permissible general requirements, that general electrical codes and the Uniform Commercial Code warranty of fitness would not be pre-empted. See ibid. The regulations even go so far as to state that § 360k(a) generally "does not preempt a state or local requirement prohibiting the manufacture of adulterated or misbranded devices" unless "such a prohibition has the effect of establishing a substantive requirement for a specific device." § 808.1(d)(6)(ii). Furthermore, under its authority to grant exemptions to the pre-emptive effect of § 360k(a), the FDA has never granted, nor, to the best of our
section 521(a) of the act because they are not 'requirements applicable to a device' within the meaning of section 521(a) of the act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the act:
"(1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e. g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.
"(2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.
. . . . . "(6)(i) Section 521(a) does not preempt State or local requirements respecting general enforcement, e. g., requirements that State inspection be permitted of factory records concerning all devices . . . .
"(ii) Generally, section 521(a) does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e. g., a specific labeling requirement, then the prohibition [may] be preempted." 21 CFR § 808.1(d) (1995).
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