482
Opinion of the Court
"(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." 5
The District Court initially denied Medtronic's motion, finding nothing in the statute to support the company's argument that the MDA entirely exempted from liability a manufacturer who had allegedly violated the FDA's regulations. See App. to Pet. for Cert. 5d. Not long after that decision, however, the United States Court of Appeals for the Eleventh Circuit concluded that § 360k required pre-emption of at least some common-law claims brought against the manu-5 Subsection (b) of the statute authorizes the FDA to grant exemptions to state requirements that would otherwise be pre-empted by subsection (a). Section 360k(b) provides: "(b) Exempt requirements
"Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—
"(1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or
"(2) the requirement— "(A) is required by compelling local conditions, and "(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter."
To carry out this grant of authority, the FDA has issued regulations under the statute which both construe the scope of § 360k(a) and address the instances in which the FDA will grant exemptions to its pre-emptive effect. See 21 CFR § 808.1 (1995); n. 18, infra.
We note that although it is the FDA that exercises this authority, the Act gives that authority directly to the Secretary of Health and Human Services, who subsequently delegated her authority to the FDA. See, e. g., 21 U. S. C. § 360k(b) ("the Secretary may" exempt state requirements), § 321(d) ("Secretary" defined as "the Secretary of Health and Human Services"). Under the FDCA, the Secretary is vested with "[t]he authority to promulgate regulations for the efficient enforcement of" the Act. 21 U. S. C. § 371(a).
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