Cite as: 518 U. S. 470 (1996)
Opinion of the Court
I
Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are "primarily, and historically, . . . matter[s] of local concern," Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 719 (1985), the "States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health, comfort, and quiet of all persons," Metropolitan Life Ins. Co. v. Massachusetts, 471 U. S. 724, 756 (1985) (internal quotation marks omitted).
Despite the prominence of the States in matters of public health and safety, in recent decades the Federal Government has played an increasingly significant role in the protection of the health of our people. Congress' first significant enactment in the field of public health was the Food and Drug Act of 1906, a broad prohibition against the manufacture or shipment in interstate commerce of any adulterated or mis-branded food or drug. See 34 Stat. 768; Regier, The Struggle for Federal Food and Drugs Legislation, 1 Law & Contemp. Prob. 1 (1933). Partly in response to an ongoing concern about radio and newspaper advertising making false therapeutic claims for both "quack machines" and legitimate devices such as surgical instruments and orthopedic shoes, in 1938 Congress broadened the coverage of the 1906 Act to include misbranded or adulterated medical devices and cosmetics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), §§ 501, 502, 52 Stat. 1049-1051; Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Prob. 2 (1939); H. R. Rep. No. 94-853, p. 6 (1976).
While the FDCA provided for premarket approval of new
drugs, Cavers, 6 Law & Contemp. Prob., at 40, it did not authorize any control over the introduction of new medical devices, see S. Rep. No. 93-670, pp. 1-2 (1974); H. R. Rep. No. 94-853, at 6. As technologies advanced and medicine
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