Chief Justice Rehnquist delivered the opinion of the Court.
Respondent represents plaintiffs who claim injuries resulting from the use of orthopedic bone screws in the pedicles of their spines. Petitioner is a consulting company that assisted the screws' manufacturer, AcroMed Corporation, in navigating the federal regulatory process for these devices. Plaintiffs say petitioner made fraudulent representations to the Food and Drug Administration (FDA or Administration) in the course of obtaining approval to market the screws. Plaintiffs further claim that such representations were at least a "but for" cause of injuries that plaintiffs sustained from the implantation of these devices: Had the representations not been made, the FDA would not have approved the devices, and plaintiffs would not have been injured. Plaintiffs sought damages from petitioner under state tort law.
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 premarket 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
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 premarket 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 substantially
In 1984, AcroMed sought § 510(k) approval for its bone screw device, indicating it for use in spinal surgery. See In re Orthopedic Bone Screw Products Liability Litigation, 159 F.3d 817, 820 (CA3 1998). The FDA denied approval on the grounds that the Class III device lacked substantial equivalence to a predicate device. See ibid. In September 1985, with the assistance of petitioner, AcroMed filed another § 510(k) application. "The application provided additional information about the . . . device and again indicated its intended use in spinal surgery. The FDA again rejected the application, determining that the device was not substantially equivalent to a predicate device and that it posed potential risks not exhibited by other spinal-fixation systems." Ibid. In December 1985, AcroMed and petitioner filed a third § 510(k) application.
Pursuant to its designation by the Judicial Panel on Multidistrict Litigation as the transferee court for In re: Orthopedic Bone Screw Liability Litigation, MDL No. 1014, the District Court for the Eastern District of Pennsylvania has been the recipient of some 2,300 civil actions related to these medical devices. Many of these actions include state-law
A divided panel of the United States Court of Appeals for the Third Circuit reversed, concluding that plaintiffs' fraud claims were neither expressly nor impliedly pre-empted. We granted certiorari, 530 U.S. 1273 (2000), to resolve a split among the Courts of Appeals on this question, see Kemp v. Medtronic, Inc., 231 F.3d 216, 233-236 (CA6 2000) (identifying split and holding such claims expressly pre-empted), and we now reverse.
Policing fraud against federal agencies is hardly "a field which the States have traditionally occupied," Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), such as to warrant a presumption against finding federal pre-emption of a state-law cause of action. To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character because the relationship originates from, is governed by, and terminates according to federal law. Cf. Boyle v. United Technologies Corp., 487 U.S. 500, 504-505 (1988) (allowing pre-emption of state law by federal common law where the interests at stake are "uniquely federal" in nature). Here, petitioner's dealings with the FDA were prompted by the MDA, and the very subject matter
Given this analytical framework, we hold that the plaintiffs' state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law.
As described in greater detail above, the § 510(k) process sets forth a comprehensive scheme for determining whether an applicant has demonstrated that a product is substantially equivalent to a predicate device. Among other information, the applicant must submit to the FDA "[p]roposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use," 21 CFR § 807.87(e) (2000), and a statement attesting to and explaining the similarities to and/or differences from similar devices (along with supporting data), see § 807.87(f). The FDA is also empowered to require additional necessary information. See § 807.87(l). Admittedly, the § 510(k) process lacks the PMA review's rigor: The former requires only a showing of substantial equivalence to a predicate device, while the latter involves a time-consuming inquiry into the risks and efficacy of each device. Nevertheless, to achieve its limited purpose, the § 510(k) process imposes upon applicants a variety of requirements that are designed to enable the FDA to
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),
This flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (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
State-law fraud-on-the-FDA claims inevitably conflict with the FDA's responsibility to police fraud consistently with the Administration's judgment and objectives. As a practical matter, complying with the FDA's detailed regulatory regime in the shadow of 50 States' tort regimes will dramatically increase the burdens facing potential applicants—burdens not contemplated by Congress in enacting the FDCA and the MDA. Would-be applicants may be discouraged from seeking § 510(k) approval of devices with potentially beneficial off-label uses for fear that such use might expose the manufacturer or its associates (such as petitioner) to unpredictable civil liability. In effect, then, fraud-on-the-FDA claims could cause the Administration's reporting requirements to deter off-label use despite the fact that the FDCA
Conversely, fraud-on-the-FDA claims would also cause applicants to fear that their disclosures to the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court. Applicants would then have an incentive to submit a deluge of information that the Administration neither wants nor needs, resulting in additional burdens on the FDA's evaluation of an application. As a result, the comparatively speedy § 510(k) process could encounter delays, which would, in turn, impede competition among predicate devices and delay health care professionals' ability to prescribe appropriate off-label uses.
Respondent relies heavily on Silkwood v. Kerr-McGee Corp., 464 U.S. 238 (1984), which it reads to "creat[e] a virtually irrefutable presumption against implied preemption of private damage remedies predicated on an alleged conflict with a federal remedial scheme." Brief for Respondent 34.
Respondent also suggests that we should be reluctant to find a pre-emptive conflict here because Congress included an express pre-emption provision in the MDA. See Brief for Respondent 37. To the extent respondent posits that anything other than our ordinary pre-emption principles apply under these circumstances, that contention must fail in light of our conclusion last Term in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), that neither an express pre-emption provision nor a saving clause "bar[s] the ordinary working of conflict pre-emption principles." Id., at 869.
We must also reject respondent's attempt to characterize both the claims at issue in Medtronic (common-law negligence action against the manufacturer of an allegedly defective pacemaker lead) and the fraud claims here as "claims arising from violations of FDCA requirements." Brief for Respondent 38. Notwithstanding the fact that Medtronic did not squarely address the question of implied pre-emption, it is clear that the Medtronic claims arose from the manufacturer's alleged failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. See 518 U. S., at 481. In the present case,
In sum, were plaintiffs to maintain their fraud-on-theagency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions. On the contrary, the existence of these federal enactments is a critical element in their case. For the reasons stated above, we think this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme.
The judgment of the Court of Appeals is reversed.
It is so ordered.
Justice Stevens, with whom Justice Thomas joins, concurring in the judgment.
As the Court points out, an essential link in the chain of causation that respondent must prove in order to prevail is that, but for petitioner's fraud, the allegedly defective orthopedic bone screws would not have reached the market. The fact that the Food and Drug Administration (FDA) has done nothing to remove the devices from the market, even though it is aware of the basis for the fraud allegations, convinces me that this essential element of the claim cannot be proved. I therefore agree that the case should not proceed.
If the FDA determines both that fraud has occurred and that such fraud requires the removal of a product from the market, state damages remedies would not encroach upon, but rather would supplement and facilitate, the federal enforcement scheme. Cf. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (holding that the presence of a state-law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but "merely provides another reason for manufacturers to comply with . . . federal law"); id., at 513 (O'Connor, J., concurring in part and dissenting in part) (same).
Briefs of amici curiae urging affirmance were filed for the Association of Trial Lawyers of America by Jeffrey Robert White and Frederick M. Baron; and for Public Citizen by Allison M. Zieve, Brian Wolfman, and Alan Morrison.