Cite as: 531 U. S. 341 (2001)
Opinion of the Court
make its statutorily required judgment as to whether the device qualifies under this exception.
Accompanying these disclosure requirements are various provisions aimed at detecting, deterring, and punishing false statements made during this and related approval processes. The FDA is empowered to investigate suspected fraud, see 21 U. S. C. § 372; 21 CFR § 5.35 (2000), and citizens may report wrongdoing and petition the agency to take action, § 10.30. In addition to the general criminal proscription on making false statements to the Federal Government, 18 U. S. C. § 1001 (1994 ed., Supp. V),3 the FDA may respond to fraud by seeking injunctive relief, 21 U. S. C. § 332, and civil penalties, 21 U. S. C. § 333(f)(1)(A); seizing the device, § 334(a)(2)(D); and pursuing criminal prosecutions, § 333(a). The FDA 4 thus has at its disposal a variety of enforcement options that allow it to make a measured response to suspected fraud upon the Administration.
This flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues diffi-cult (and often competing) objectives. For example, with respect to Class III devices, the FDA simultaneously maintains the exhaustive PMA and the more limited § 510(k) processes in order to ensure both that medical devices are
3 Title 18 U. S. C. § 1001(a) (1994 ed., Supp. V) provides: "[W]hoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully falsifies, conceals or covers up by any trick, scheme, or device a material fact; [or] makes any materially false, fictitious or fraudulent statement or representation; or makes or uses any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry; shall be fined under this title or imprisoned not more than 5 years, or both."
4 The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions: "[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States." 21 U. S. C. § 337(a).
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