Cite as: 531 U. S. 341 (2001)
Opinion of the Court
the FDA's review requires an "average of 1,200 hours [for] each submission." Medtronic, Inc. v. Lohr, 518 U. S. 470, 477 (1996) (citing Hearings before the Subcommittee on Health and the Environment of the House Committee on Energy & Commerce, 100th Cong., 1st Sess. (Ser. No. 100-34), p. 384 (1987); Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 512-514 (1984)).
An exception to the PMA requirement exists for devices that were already on the market prior to the MDA's enactment in 1976. See 21 U. S. C. § 360e(b)(1)(A). The MDA allows these "predicate" devices to remain available until the FDA initiates and completes the PMA process. In order to avoid the potentially monopolistic consequences of this predicate-device exception, the MDA allows other manufacturers to distribute (also pending completion of the predicate device's PMA review) devices that are shown to be "substantially equivalent" to a predicate device. § 360e(b)(1)(B).
Demonstrating that a device qualifies for this exception is known as the "§ 510(k) process," which refers to the section of the original MDA containing this provision. Section 510(k) submissions must include the following: "Proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use," 21 CFR § 807.87(e) (2000); "[a] statement indicating the device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement," § 807.87(f); "[a] statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the pre-market notification are truthful and accurate and that no material fact has been omitted," § 807.87(k); and "[a]ny additional information regarding the device requested by the [FDA] Commissioner that is necessary for the Commissioner to make a finding as to whether or not the device is substan-
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