500
Opinion of the Court
knowledge, even been asked to consider granting, an exemption for a state law of general applicability; all 22 existing exemptions apply to excruciatingly specific state requirements regarding the sale of hearing aids. See §§ 808.53-808.101.
Although we do not believe that this statutory and regulatory language necessarily precludes "general" federal requirements from ever pre-empting state requirements, or "general" state requirements from ever being pre-empted, see Part VI, infra, it is impossible to ignore its overarching concern that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be "with respect to" medical devices and "different from, or in addition to," federal requirements. State requirements must also relate "to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device," and the regulations provide that state requirements of "general applicability" are not pre-empted except where they have "the effect of establishing a substantive requirement for a specific device." Moreover, federal requirements must be "applicable to the device" in question, and, according to the regulations, pre-empt state law only if they are "specific counterpart regulations" or "specific" to a "particular device." The statute and regulations, therefore, require a careful comparison between the allegedly pre-empting federal requirement and the allegedly pre-empted state requirement to determine whether they fall within the intended pre-emptive scope of the statute and regulations.19
19 A plurality of this Court concluded in Cipollone that a similar analysis was required under the Public Health Cigarette Smoking Act of 1969. That Act pre-empted requirements and prohibitions based on smoking and health "imposed under State law with respect to the advertising or promotion" of cigarettes in packages that were labeled in conformity with that Act. 505 U. S., at 515. We held that the petitioner's fraudulent misrepresentation claims, including those based on allegedly false statements made in advertisements, were not pre-empted because they were "predicated not on a duty 'based on smoking and health' but rather on a more general
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