344
Opinion of the Court
We hold that such claims are pre-empted by the Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended by the Medical Device Amendments of 1976 (MDA), 90 Stat. 539, 21 U. S. C. § 301 (1994 ed. and Supp. V).
I
Regulation of medical devices is governed by the two Acts just named. The MDA separates devices into three categories: Class I devices are those that present no unreasonable risk of illness or injury and therefore require only general manufacturing controls; Class II devices are those possessing a greater potential dangerousness and thus warranting more stringent controls; Class III devices "presen[t] a potential unreasonable risk of illness or injury" and therefore incur the FDA's strictest regulation. § 360c(a)(1)(C)(ii)(II). It is not disputed that the bone screws manufactured by AcroMed are Class III devices.
Class III devices must complete a thorough review process with the FDA before they may be marketed. This pre-market approval (PMA) process requires the applicant to demonstrate a "reasonable assurance" that the device is both "safe . . . [and] effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." §§ 360e(d)(2)(A), (B). Among other information, an application must include all known reports pertaining to the device's safety and efficacy, see § 360e(c)(1)(A); "a full statement of the components, ingredients, and properties and of the principle or principles of operation of such device," § 360e(c)(1)(B); "a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device," § 360e(c)(1)(C); samples of the device (when practicable), see § 360e(c)(1)(E); and "specimens of the labeling proposed to be used for such device," § 360e(c)(1)(F). The PMA process is ordinarily quite time consuming because
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