476
Opinion of the Court
relied to an increasing degree on a vast array of medical equipment "[f]rom bedpans to brainscans," 1 including kidney dialysis units, artificial heart valves, and heart pacemakers,2 policymakers and the public became concerned about the increasingly severe injuries that resulted from the failure of such devices. See generally Finck, The Effectiveness of FDA Medical Device Regulation, 7 U. C. D. L. Rev. 293, 297- 301 (1974); H. R. Rep. No. 94-853, at 7.
In 1970, for example, the Dalkon Shield, an intrauterine contraceptive device, was introduced to the American public and throughout the world. Touted as a safe and effective contraceptive, the Dalkon Shield resulted in a disturbingly high percentage of inadvertent pregnancies, serious infections, and even, in a few cases, death. Id., at 8; Regulation of Medical Devices (Intrauterine Contraceptive Devices), Hearings before a Subcommittee of the House Committee on Government Operations, 93d Cong., 1st Sess. (1973). In the early 1970's, several other devices, including catheters, artificial heart valves, defibrillators, and pacemakers (including pacemakers manufactured by petitioner Medtronic), attracted the attention of consumers, the Food and Drug Administration (FDA), and Congress as possible health risks. See Medical Device Amendments, 1973, Hearings before the Subcommittee on Health of the Senate Committee on Labor and Public Welfare, 93d Cong., 2d Sess., 270-361 (1973).
In response to the mounting consumer and regulatory concern, Congress enacted the statute at issue here: the Medical Device Amendments of 1976 (MDA or Act), 90 Stat. 539. The Act classifies medical devices in three categories based on the risk that they pose to the public. Devices that pre-1 Medical Device Regulation: The FDA's Neglected Child (Committee Print compiled for the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce), Comm. Print 98-F, p. 1 (1983).
2 S. Rep. No. 94-33, p. 5 (1975).
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