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The question presented is whether that statute preempts a state commonlaw negligence action against the manufacturer of an allegedly defective medical device. Specifically, we must consider whether Lora Lohr, who was injured when her pacemaker failed, may rely on Florida common law to recover damages from Medtronic, Inc., the manufacturer of the device.  9H1 d d8I؃  2  Throughout our history the several States have exercised their police powers to protect the health and """## safety of their citizens. Because these are primarily, and historically, ... matter[s] of local concern,  J ԚHillsborough County v. Automated Medical Laboratories,  J Inc., 471 U.S. 707, 719 (1985), the States traditionally have had great latitude under their police powers to legislate as to the protection of the lives, limbs, health,  J comfort, and quiet of all persons. Metropolitan Life Ins.  J Co. v. Massachusetts, 471 U.S. 724, 756 (1985) (internal quotation marks omitted).  Despite the prominence of the States in matters of public health and safety, in recent decades the Federal Government has played an increasingly significant role in the protection of the health of our people. Congress' first significant enactment in the field of public health was the Food and Drug Act of 1906, a broad prohibition against the manufacture or shipment in interstate commerce of any adulterated or misbranded food or drug. See 34 Stat. 768; Regier, The Struggle for Federal Food and Drugs Legislation, 1 Law. & Contemp. Probs. 1 (1933). Partly in response to an ongoing concern about radio and newspaper advertising making false therapeutic claims for both quack machines and legitimate devices such as surgical instruments and orthopedic shoes, in 1938 Congress broadened the coverage of the 1906 Act to include misbranded or adulterated medical devices and cosmetics. See Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 501, 502, 52 Stat. 1049!1051; Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 Law & Contemp. Probs. 2 (1939); H.R. Rep. No. 94!853, p.6 (1976).  While the FDCA provided for premarket approval of new drugs, Cavers, 6 Law & Contemp. Probs., at 40, it did not authorize any control over the introduction of new medical devices, see S. Rep. No. 93!670, pp. 1!2 (1974); H.R. Rep. 94!853, at 6. As technologies advanced and medicine relied to an increasing degree on`""#  a vast array of medical equipment [f]rom bedpans to  J brainscans,+i uB@ ԍ FTN    XgEpXFr  ddf < 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).+ including kidney dialysis units, artificial  J heart valves, and heart pacemakers,uli uB ԍ FTN    XgEpXFr  ddf < S. Rep. No. 94!33, p. 5 (1975).u 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. 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,  J 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, 93rd 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 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, 93rd 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. P#"   Devices that present no unreasonable risk of illness or injury are designated Class I and are subject only to minimal regulation by general controls. 21 U.S.C. 360c(a)(1)(A). Devices that are potentially more harmful are designated Class II; although they may be marketed without advance approval, manufacturers of such devices must comply with federal performance regulations known as special controls. 360c(a)(1)(B). Finally, devices that either present a potential unreasonable risk of illness or injury, or which are purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, are designated Class III. 360c(a)(1)(C). Pacemakers are Class III devices. See 21 CFR 870.3610 (1995).  Before a new Class III device may be introduced to the market, the manufacturer must provide the FDA with a reasonable assurance that the device is both safe and effective. See 21 U.S.C. 360e(d)(2). Despite its relatively innocuous phrasing, the process of establishing this reasonable assurance, which is known as the premarket approval, or PMA process, is a rigorous one. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission. 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) (hereinafter 1987 Hearings); see generally Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 512!514 (1984).  Not all, nor even most, Class III devices on the market today have received premarket approval because of two important exceptions to the PMA requirement. `"   First, Congress realized that existing medical devices could not be withdrawn from the market while the FDA completed its PMA analysis for those devices. The statute therefore includes a grandfathering provision which allows pre1976 devices to remain on the market without FDA approval until such time as the FDA initiates and completes the requisite PMA. See 21  J U.S.C. 360e(b)(1)(A); 21 CFR 814.1(c)(1). i uBP ԍ FTN    XgEpXFr  ddf < The FDA has not yet initiated nor suggested the initiation of a PMA process for pacemakers or most other grandfathered devices. But see 60 Fed. Reg. 41984, 41986 (1995) (pursuant to Safe Medical Devices Act of 1990, 104 Stat. 4511, calling for submission of information by February 1997 which may lead the FDA to reclassify or initiate PMA process at some time in the future for implantable pacemaker pulse generators and lead adapters).  Second, to prevent manufacturers of grandfathered devices from monopolizing the market while new devices clear the PMA hurdle, and to ensure that improvements to existing devices can be rapidly introduced into the market, the Act also permits devices that are substantially equivalent to preexisting devices to avoid the PMA process. See 21 U.S.C. 360e(b)(1)(B).  Although substantially equivalent Class III devices may be marketed without the rigorous PMA review, such new devices, as well as all new Class I and Class II devices, are subject to the requirements of 360(k). That section imposes a limited form of review on every manufacturer intending to market a new device by requiring it to submit a premarket notification to the FDA (the process is also known as a 510(k) process, after the number of the section in the original Act). If the FDA concludes on the basis of the 510(k) notification that the device is substantially equivalent to a preexisting device, it can be marketed without further regulatory analysis (at least until the FDA initiates the PMA process for the underlying pre1976 device to which"   the new device is substantially equivalent). The 510(k) notification process is by no means comparable to the PMA process; in contrast to the 1,200 hours necessary to complete a PMA review, the 510(k) review is completed in an average of only 20 hours. See 1987 Hearings, at 384. As one commentator noted, [t]he attraction of substantial equivalence to manufacturers is clear. [Section] 510(k) notification requires little information, rarely elicits a negative response from the FDA, and gets processed very quickly. Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L. J. 511, 516 (1988); see also Kahan, 39 Food Drug Cosm. L. J., at 514!519.  Congress anticipated that the FDA would complete the PMA process for Class III devices relatively swiftly. But because of the substantial investment of time and energy necessary for the resolution of each PMA application, the everincreasing numbers of medical devices, and internal administrative and resource difficulties, the FDA simply could not keep up with the rigorous PMA process. As a result, the 510(k) premarket notification process became the means by which most new medical devices"including Class III devices"were approved for the market. In 1983, for instance, a House Report concluded that nearly 1,000 of approximately 1,100 Class III devices that had been introduced to the market since 1976 were admitted as substantial equivalents and  J without any PMA review. See  FTN  O XgEpXFr  ff 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. 34 (1983). This lopsidedness has apparently not evened out; despite an increasing effort by the FDA to consider the safety and efficacy of substantially equivalent devices, the House reported in 1990 that 80% of new Class III devices were`"   being introduced to the market through the 510(k) process and without PMA review. H.R. Rep. No. 101!808, p. 14 (1990); see also D. Kessler, S. Pape, & D. Sundwall, The Federal Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987) (55 510(k) notifications are filed for each PMA application; average FDA response to 510(k) notification is onefifth the  J response time to a PMA).I uBP ԍ FTN    XFrXFr ddf < In 1990, Congress enacted amendments to the MDA which were designed to reduce the FDA's reliance on the 510(k) process while continuing to ensure that particularly risky devices received full PMA review. See Safe Medical Devices Act of 1990.I  9H1 d d7II؃  2  As have so many other medical device manufacturers, petitioner Medtronic took advantage of 510(k)'s expedited process in October of 1982, when it notified FDA that it intended to market its Model 4011 pacemaker lead as a device that was substantially equivalent to devices already on the market. (The lead is the portion of a pacemaker that transmits the heartbeatsteadying electrical signal from the pulse generator to the heart itself.) On November 30, 1982, the FDA found that the model was substantially equivalent to devices introduced into interstate commerce prior to the effective date of the Act, and advised Medtronic that it could therefore market its device subject only to the general control provisions of the Act, which could be found in the Code of Federal Regulations. See Respondent's Memorandum in Support of Motion for Summary Judgment in No. 93!482 (MD Fla., Nov. 1, 1993), Exh. A to Exh. 1 (Declaration of Charles H. Swanson) (hereinafter FDA Substantial Equivalence Letter). The agency emphasized, however, that this determination should not be construed as an endorsement of the pacemaker lead's  J safety. Ibid.l"  Ԍ Crosspetitioner Lora Lohr is dependent on pacemaker technology for the proper functioning of her heart. In 1987 she was implanted with a Medtronic pacemaker equipped with one of the company's Model 4011 pacemaker leads. On December 30, 1990, the pacemaker failed, allegedly resulting in a complete heart block that required emergency surgery. According to her physician, a defect in the lead was the likely cause of the failure.  In 1993 Lohr and her husband filed this action in a Florida state court. Their complaint contained both a negligence count and a strict liability count. The negligence count alleged a breach of Medtronic's duty to use reasonable care in the design, manufacture, assembly, and sale of the subject pacemaker in several respects, including the use of defective materials in the lead and a failure to warn or properly instruct the plaintiff or her physicians of the tendency of the pacemaker to fail, despite knowledge of other earlier failures. Complaint 5. The strict liability count alleged that the device was in a defective condition and unreasonably danger J ous to foreseeable users at the time of its sale. Id.,  J 11. ( FTN    XFrXFr ff A third count alleging breach of warranty was dismissed for failure to state a claim under Florida law.)  Medtronic removed the case to Federal District Court, where it filed a motion for summary judgment arguing that both the negligence and strict liability claims were preempted by 21 U.S.C. 360k(a). That section, which is at the core of the dispute between the parties in this case, provides: BQ (C  , , (   360k. State and local requirements respecting devices (a) General rule - - " Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a"   device intended for human use any requirement" - - " (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and - - " (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this  J chapter.1 B uBP ԍ FTN    XFrXFr ddf < Subsection (b) of the statute authorizes the FDA to grant exemptions to state requirements that would otherwise be preempted by  uB subsection (a).  FTN   XFrXFr ff Section 360k(b) provides: (b) Exempt requirements   Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a) of this section, under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if"   (1) the requirement is more stringent than a requirement under this chapter which would be applicable to the device if an exemption were not in effect under this subsection; or   (2) the requirement"   (A) is required by compelling local conditions, and   (B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this chapter.  uBw  To carry out this grant of authority, the FDA has issued regulations under the statute which both construe the scope of 360k(a) and address the instances in which the FDA will grant exemptions  uB to its preemptive effect. See 21 CFR 808.1 (1995); infra, n.18.  We note that although it is the FDA that exercises this authority, the Act gives that authority directly to the Secretary of Health and Human Services, who subsequently delegated her authority to the  uBx FDA. See, e.g., 21 U.S.C. 360k(b) ( the Secretary may exempt state requirements), 321(d) ( Secretary defined as the Secretary of Health and Human Services). Under the FDCA, the Secretary is vested with [t]he authority to promulgate regulations for the efficient enforcement of the Act. 21 U.S.C. 371(a).1 QBQ d   ( , ,  The District Court initially denied Medtronic's motion, finding nothing in the statute to support the company's K"   argument that the MDA entirely exempted from liability a manufacturer who had allegedly violated the FDA's regulations. See App. to Pet. for Cert. 5d. Not long after that decision, however, the United States Court of Appeals for the Eleventh Circuit concluded that 360k required preemption of at least some commonlaw claims brought against the manufacturer of a medical  J device. See Duncan v. Iolab Corp., 12 F.3d 194 (1994).  J After reconsidering its ruling in light of Duncan, the District Court reversed its earlier decision and dismissed the Lohrs' entire complaint.  The Court of Appeals reversed in part and affirmed in part. 56 F.3d 1335 (CA11 1995). Rejecting the Lohrs' broadest submission, it first decided that common law actions are state requirements within the meaning of  J 360k(a). Id., at 1342. It next held that preemption could not be avoided by merely alleging that the negli JX gence flowed from a violation of federal standards. Id., at 1343. Then, after concluding that the term requirements in 360k(a) was unclear, it sought guidance from FDA's regulations regarding preemption. Those regulations provide that a state requirement is not preempted unless the FDA has established  ! `specific requirements  Jh applicable to a particular device.' !  Id., at 1344 (citing 21 CFR 808.1(d) (1995)). Under these regulations, the court concluded, it was not necessary that the federal regulation specifically deal with pacemakers, but only that the federal requirement should, in some way, be `restricted by nature' to a particular process, procedure, or device and should not be completely openended, 56 F.3d, at 1346, and that the specific device at issue should be subject to its requirements.  Under this approach, the Court concluded that the Lohrs' negligent design claims were not preempted. It rejected Medtronic's argument that the FDA's finding of substantial equivalence had any significance with respect to the pacemaker's safety, or that the FDA's` "   continued surveillance of the device constituted a federal  J  requirement that its design be maintained. Id., at 1347!1349. On the other hand, it concluded that the negligent manufacturing and failure to warn claims were preempted by FDA's general good manufacturing practices regulations, which establish general requirements for most steps in every device's manufacture, see  J id., at 1350; 21 CFR 820.20!820.198 (1995), and by the FDA labeling regulations, which require devices to bear various warnings, see 56 F.3d, at 1350!1351; 21 CFR 801.109 (1995). The Court made a parallel disposition of the strict liability claims, holding that there was no preemption insofar as plaintiffs alleged an unreasonably dangerous design, but they could not revive the negligent manufacturing or failure to warn claims under a strict liability theory. 56 F.3d, at 1351!1352.  Medtronic filed a petition for certiorari seeking review of the Court of Appeals' decision insofar as it affirmed the District Court and the Lohrs filed a crosspetition seeking review of the judgment insofar as it upheld the preemption defense. Because the Courts of Appeals are divided over the extent to which state commonlaw  Jh claims are preempted by the MDA,l&h uB   FTN  &  XFrXFr ddf < See, e.g., English v. Mentor Corp., 67 F.3d 477 (CA3 1995)  uB (510(k) process creates preemptive requirements); Feldt v. Mentor  uB> Corp., 61 F.3d 431 (CA5 1995) (510(k) process does not create pre uB emptive requirements); Michael v. Shiley Inc., 46 F.3d 1316 (CA3 1995) (claim alleging violation of federal requirement not preempted); 56 F.3d 1335 (CA11 1995) (case below) (claim alleging violation of federal requirement may be preempted; 510(k) process may create preemptive requirements; commonlaw claims covered by  uB 360k(a)); Kennedy v. Collagen Corp., 67 F.3d 1453 (CA9 1995) (commonlaw claims not covered at all by 360k(a)).l we granted both petitions. 516 U.S. ___ (1996).  9H1 d "  Ԍdy7III؃  J  2  As in Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992), we are presented with the task of interpreting a statutory provision that expressly preempts state law. While the preemptive language of 360k(a) means that we need not go beyond that language to determine whether Congress intended the MDA to preempt at  J least some state law, see id., at 517, we must nonetheless identify the domain expressly preempted by that  J language. Ibid. Although our analysis of the scope of the preemption statute must begin with its text, see  Jz Gade v. National Solid Wastes Management Assn., 505  JR U.S. 88, 111 (1992) (Kennedy, J., concurring in part and concurring in judgment), our interpretation of thatlanguage does not occur in a contextual vacuum. Rather, that interpretation is informed by two presump J tions about the nature of preemption. See ibid.  First, because the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly preempt statelaw causes of action. In all preemption cases, and particularly in those in which Congress has legislated ... in a field  J which the States have traditionally occupied, Rice v.  J Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947), we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest  J purpose of Congress. Id., at 230; Hillsborough Cty.,  J 471 U.S., at 715!716; cf. Fort Halifax Packing Co. v.  J Coyne, 482 U.S. 1, 22 (1987).  FTN  g XFrXFr ff Although dissenting Justices have argued that this assumption should apply only to the question whether Congress intended any preemption at all, as opposed to questions concerning  J  the scope of its intended invalidation of state law, see  J Cipollone, 505 U.S., at 545!546 (Scalia, J., concurring in judgment in part, and dissenting in part), we used a presumption against the preemption of state police "   power regulations to support a narrow interpretation of  J such an express command in Cipollone. Id., at 518, 523. That approach is consistent with both federalism concerns and the historic primacy of state regulation of matters of health and safety.  Second, our analysis of the scope of the statute's preemption is guided by our oftrepeated comment, initially  J made in Retail Clerks v. Schermerhorn, 375 U.S. 96, 103 (1963), that [t]he purpose of Congress is the ulti J mate touchstone in every preemption case. See, e.g.,  Jp Cipollone, 505 U.S., at 516; Gade, 505 U.S., at 96;  JH Malone v. White Motor Corp., 435 U.S. 497, 504 (1978). As a result, any understanding of the scope of a preemption statute must rest primarily on a fair under J standing of congressional purpose. Cipollone, 505 U.S.,  J at 530, n. 27 (opinion of Stevens, J.). Congress' intent, of course, primarily is discerned from the language of the preemption statute and the statutory framework  J0 surrounding it. Gade, 505 U.S., at 111 (Kennedy, J., concurring in part and concurring in judgment). Also relevant, however, is the structure and purpose of the  J statute as a whole, id., at 98 (opinion of O'Connor, J.), as revealed not only in the text, but through the reviewing court's reasoned understanding of the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law.  With these considerations in mind, we turn first to a consideration of petitioner Medtronic's claim that the Court of Appeals should have found the entire action preempted and then to the merits of the Lohrs' crosspetition.  9H1 d d7IV؃  <2  In its petition, Medtronic argues that the Court of Appeals erred by concluding that the Lohrs' claims alleging negligent design were not preempted by 21 "   U.S.C. 360k(a). That section provides that no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under thischapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter. Medtronic suggests that any commonlaw cause of action is a requirement which alters incentives and imposes duties different from, or in addition to the generic federal standards that the FDA has promulgated in response to mandates under the MDA. In essence, the company argues that the plain language of the statute preempts any and all commonlaw claims brought by an injured plaintiff against a manufacturer of medical devices.  Medtronic's argument is not only unpersuasive, it is implausible. Under Medtronic's view of the statute, Congress effectively precluded state courts from affording state consumers any protection from injuries resulting from a defective medical device. Moreover, because there is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action, Congress would have barred most, if not all, relief for  J persons injured by defective medical devices.C uBX ԍ FTN    XFrXFr ddf < The FDA's authority to require manufacturers to recall, replace, or refund defective devices is of little use to injured plaintiffs, since there is no indication that the right is available to private parties, the remedy would not extend to recovery for compensatory damages, and the authority is rarely invoked, if at all. See Adler, The 1976 Medical Device Amendments: A Step in the Right Direction Needs Another Step in the Right Direction, 43 Food Drug Cosm. L. J. 511, 526!527 (1988).C Medtronic's construction of 360k would therefore haveH"   the perverse effect of granting complete immunity from design defect liability to an entire industry that, in the judgment of Congress, needed more stringent regulation in order to provide for the safety and effectiveness of medical devices intended for human use, 90 Stat. 539 (preamble to Act). It is, to say the least, difficult to believe that Congress would, without comment, remove all means of judicial recourse for those injured by illegal  J conduct, Silkwood v. KerrMcGee Corp., 464 U.S. 238, 251 (1984), and it would take language much plainer than the text of 360k to convince us that Congress intended that result.  Furthermore, if Congress intended to preclude all commonlaw causes of action, it chose a singularly odd word with which to do it. The statute would have achieved an identical result, for instance, if it had precluded any remedy under state law relating to medical devices. Requirement appears to presume that the State is imposing a specific duty upon the manufacturer, and although we have on prior occasions concluded that a statute preempting certain state requirements could also preempt commonlaw damages claims, see  J ԚCipollone, 505 U.S., at 521!522 (opinion of Stevens,  Jh J.), that statute did not sweep nearly as broadly as Medtronic would have us believe that this statute does.  J  The preemptive statute in Cipollone uB ԍ FTN    XFrXFr ddf < There were actually two preemptive statutes at issue: The first, enacted in 1965, provided that [n]o statement relating to smoking and health ... shall be required on any cigarette package or in  uB any cigarette advertising. See Cipollone v. Liggett Group, Inc., 505 U.S., at 514. That provision, the Court concluded, did not preempt  uB any of the petitioner's commonlaw claims. Id., at 518!520. In 1969, Congress superseded the 1965 preemption statute with part of the Public Health Cigarette Smoking Act of 1969, which provided that [n]o requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in"##  uB conformity with the provisions of this Act. Id., at 515. The bulk  uBG of Cipollone's analysis involved this later statute; unless otherwise stated, it is this statute to which we refer in subsequent references  uB to the preemptive statute in Cipollone. was targeted atl"   a limited set of state requirements"those based on smoking and health"and then only at a limited subset of the possible applications of those requirements"those involving the advertising or promotion of any cigarettes the packages of which are labeled in conformity with  J8 the provisions of the federal statute. See id., at 515. In that context, giving the term requirement its widest reasonable meaning did not have nearly the preemptive scope nor the effect on potential remedies that Medtronic's broad reading of the term would have in  Jp this case. The Court in Cipollone held that the petitioner in that case was able to maintain some commonlaw actions using theories of the case that did not run  J afoul of the preemption statute. See id., at 524!530. Here, however, Medtronic's sweeping interpretation of the statute would require far greater interference with state legal remedies, producing a serious intrusion into state sovereignty while simultaneously wiping out the  J0 possibility of remedy for the Lohrs' alleged injuries.c 0l uBt ԍ FTN    XFrXFr ddf < Unlike 360k, the preemptive effect of the statute in Cipollone was not dependent on the issuance of any agency regulations. The territory exclusively occupied by federal law was defined in the text of the statute itself; that text specified the precise warning to smokers that Congress deemed both necessary and sufficient. In the MDA, no such specifics exist until the FDA provides them. See also  uB infra, at 24 (reliance on the FDA's interpretation of 360k war uBu ranted, inter alia, because of the FDA's role in the administration of  uB, 360k). Moreover, the statute in Cipollone was clearly intended to have a broader preemptive effect than its 1965 predecessor. See 505 U.S., at 515, 520!521.c Given the ambiguities in the statute and the scope of the preclusion that would occur otherwise, we cannot accept Medtronic's argument that by using the termI "   requirement, Congress clearly signaled its intent to deprive States of any role in protecting consumers from the dangers inherent in many medical devices.  Other differences between this statute and the one in  J` Cipollone further convince us that when Congress enacted 360k, it was primarily concerned with the problem of specific, conflicting State statutes and regulations rather than the general duties enforced by commonlaw  J actions. Unlike the statute at issue in Cipollone, 360k refers to requirements many times throughout its text. In each instance, the word is linked with language suggesting that its focus is devicespecific enactments of positive law by legislative or administrative bodies, not the application of general rules of common law by judges and juries. For instance, subsections (a)(2) and  J (b) of the statute  uB ԍ FTN  &  XFrXFr ddf < The text of the statute is quoted supra, at 9, and n.5. also refer to requirements"but those requirements refer only to statutory and regulatory law that exists pursuant to the MDA itself, suggesting that the preempted requirements established or continued by States also refer primarily to positive enactments of state law. Moreover, in subsection (b) the FDA is given authority to exclude certain requirements from the scope of the preemption statute. Of the limited number of exemptions from preemption that the FDA has granted, none even remotely resemble  J commonlaw claims. %G uB7 ԍ FTN  &  XFrXFr ddf < All 22 exemptions at 21 CFR 808.53!808.101 (1995) are exemptions for state statutes and regulations regarding the sale of hearing aids.  An examination of the basic purpose of the legislation as well as its history entirely supports our rejection of Medtronic's extreme position. The MDA was enacted to provide for the safety and effectiveness of medical devices intended for human use. 90 Stat. 539. Medtronic asserts that the Act was also intended, however, to(l "   protect innovations in device technology from being `stifled by unnecessary restrictions,' !  Brief for Petitioners in No. 95!754, p. 3 (citing H.R. Rep. 94!853, at 12), and that this interest extended to the preemption of commonlaw claims. While the Act certainly reflects  J8 some of these concerns,  8 uB ԍ FTN  &  XFrXFr ddf < Special statutory exemptions, for example, permit the FDA (with various oversight provisions) to allow investigative, experimental devices to be used in commerce without either PMA review or substantial equivalence. See 21 U.S.C. 360j(g); 21 CFR pt. 813 (1995). Moreover, the very existence of the preemption statute demonstrates some concern that competing state requirements may unduly interfere with the market for medical devices.  the legislative history indicates that any fears regarding regulatory burdens were relat J ed more to the risk of additional federal and state regulation rather than the danger of preexisting duties  J under common law. See, e.g., 122 Cong. Rec. 5850 (Mar. 9, 1976) (statement of Rep. Collins) (opposing further redundant and burdensome Federal require J ments); id., at 5855 (discussing efforts taken in MDA to protect small businesses from the additional requirements of the Act). Indeed, nowhere in the materials relating to the Act's history have we discovered a reference to a fear that product liability actions would hamper the development of medical devices. To the extent that Congress was concerned about protecting the industry, that intent was manifested primarily through fewer substantive requirements under the Act, not the preemption provision; furthermore, any such concern was far outweighed by concerns about the primary issue motivating the MDA's enactment: the safety of those who use medical devices.  The legislative history also confirms our understanding that 360(k) simply was not intended to preempt most, let alone all, general commonlaw duties enforced by damages actions. There is, to the best of our knowl "  Ԯedge, nothing in the hearings, the committee reports, or the debates suggesting that any proponent of the legislation intended a sweeping preemption of traditional commonlaw remedies against manufacturers and distributors of defective devices. If Congress intended such a result, its failure even to hint at it is spectacularly odd, particularly since Members of both Houses were  J acutely aware of ongoing product liability litigation.  uBP ԍ FTN  &  XFrXFr ddf < Furthermore, if Congress had intended the MDA to work this dramatic change in the availability of statelaw remedies, one would expect some reference to that change in the extensive contemporary reviews of the legislation. We have been able to find no such  uB, reference. See, e.g., Lesparre, Industry Spokesman Comments on Medical Device Amendments of 1976, 50 Hospitals 99, 103 (Sept. 16, 1976); A. Levine, Device Failure and the Plaintiff's Lawyer, in Proceedings of the Second Annual AAMI/FDA Conference on Medical Device Regulation 54 (1975); Medical Device Amendments of 1975, Hearings Before the Subcommittee on Health and the Environment of the House Committee on Interstate and Foreign Commerce, Ser. No. 94!39, 94th Cong., 1st Sess., 271 (1975) (statement of Anita Johnson, Public Citizen's Health Research Group) (arguing that the preemption provision should not be included, but making no mention of common law, and specifically discussing only a positive California enactment regarding the safety of intrauterine contraceptive devices); Medical Devices and Equipment Liability Avoidance (Frost & Sullivan pub. June 1977) (comprehensive 2"volume, 600"page review of published medical device product liability cases from 1910 to 1976, suggesting nowhere that MDA had mooted or even altered the longstanding ability of plaintiffs to seek and receive damages awards under state law). Along with the lessthanprecise language of 360k(a), that silence surely indicates that at least some commonlaw claims against medical device manufacturers may be maintained after the enactment of the MDA.  9H1 d d8V؃  \ 2  Medtronic asserts several specific reasons why, even if 360k does not preempt all commonlaw claims, it at least preempts the Lohrs' claims in this case. In con> J "  Ԯtrast, the Lohrs argue that their entire complaint should survive a reasonable evaluation of the preemptive scope of 360k(a). First, the Lohrs claim that the Court of Appeals correctly held that their negligent design claims were not preempted because the 510(k) premarket notification process imposes no requirement on the design of Medtronic's pacemaker. Second, they suggest that even if the FDA's general rules regulating manufacturing practices and labeling are requirements  J that preempt different state requirements, 360k(a) does not preempt state rules that merely duplicate some or all of those federal requirements. Finally, they argue that because the State's general rules imposing commonlaw duties upon Medtronic do not impose a requirement with respect to a device, they do not conflict with the FDA's general rules relating to manufacturing and labeling and are therefore not preempted.  J0 Design Claim  !  The Court of Appeals concluded that the Lohrs' defective design claims were not preempted because the requirements with which the company had to comply were not sufficiently concrete to constitute a preempting federal requirement. Medtronic counters by pointing to the FDA's determination that Model 4011 is substantially equivalent to an earlier device as well as the agency's continuing authority to exclude the device from the market if its design is changed. These factors, Medtronic argues, amount to a specific, federally enforceable design requirement that cannot be affected by statelaw pressures such as those imposed on manufacturers subject to product liability suits.  The company's defense exaggerates the importance of the 510(k) process and the FDA letter to the company regarding the pacemaker's substantial equivalence to a grandfathered device. As the court below noted, [t]he  J 510(k) process is focused on equivalence, not safety. 56 "   F.3d, at 1348. As a result, substantial equivalence determinations provide little protection to the public. These determinations simply compare a post1976 device to a pre1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective. Adler, 43 Food Drug Cosm. L. J., at 516. The design of the Model 4011, as with the design of pre1976 and other substantially equivalent devices, has never been formally reviewed under the MDA for safety or efficacy.  The FDA stressed this basic conclusion in its letter to Medtronic finding the 4011 lead substantially equivalent to devices already on the market. That letter only required Medtronic to comply with general standards"the lowest level of protection applicable to all medical devices, and including listing of devices, good manufacturing practices, labeling, and the misbranding and adulteration provisions of the Act. It explicitly warned Medtronic that the letter did not in any way denote official FDA approval of your device, and that [a]ny representation that creates an impression of official approval of this device because of compliance with the premarket notification regulations is misleading and constitutes misbranding. FDA Substantial Equivalence Letter.  Thus, even though the FDA may well examine 510(k) applications for Class III devices (as it examines the entire medical device industry) with a concern for the safety and effectiveness of the device, see Brief for Petitioner in No. 95!754, pp. 22!26, it did not require Medtronics' pacemaker to take any particular form for any particular reason; the agency simply allowed the pacemaker, as a device substantially equivalent to one that existed before 1976, to be marketed without running the gauntlet of the PMA process. In providing for` "   this exemption to PMA review, Congress intended merely to give manufacturers the freedom to compete, to a limited degree, with and on the same terms as manufac J turers of medical devices that existed prior to 1976.  uB ԍ FTN  &  XFrXFr ddf < As the FDA Commissioner put it in 1982, the 510(k) provision of the law is a procompetition mechanism that permits firms to make and quickly market metoo versions of pre1976 devices. The Congress apparently believed that a firm whose device happened to be on the market before enactment of the amendments and was never subject to preclearance by FDA should not enjoy a lengthy monopoly at the expense of other firms and ultimately the consumer. FDA Oversight: Medical Devices, Hearing before the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, 97th Cong., 2d Sess., 9 (1982). See also Kahan, Premarket Approval Versus Premarket Notification: Different Routes to the Same Market, 39 Food Drug Cosm. L. J. 510, 514!515 (1984); D. Kessler, S. Pape, & D. Sundwall, The Federal Regulation of Medical Devices, 317 New England J. Med. 357, 359 (1987). There is no suggestion in either the statutory scheme or the legislative history that the 510(k) exemption process was intended to do anything other than maintain the status quo with respect to the marketing of existing medical devices and their substantial equivalents. That status quo included the possibility that the manufacturer of the device would have to defend itself against statelaw claims of negligent design. Given this background behind the substantial equivalence exemption, the fact that [t]he purpose of Congress is the ultimate touchstone in every preemption case, 505 U.S., at 516 (internal quotation marks and citations omitted), and the presumption against preemption, the Court of Appeals properly concluded that the substantial equivalence provision did not preempt the Lohrs' design claims.  J Identity of Requirements Claims  !  The Lohrs next suggest that even if requirements "   exist with respect to the manufacturing and labeling of the pacemaker, and even if we can also consider state law to impose a requirement under the Act, the state requirement is not preempted unless it is different from, or in addition to, the federal requirement. 360k(a)(1). Although the precise contours of their theory of recovery have not yet been defined (the preemption issue was decided on the basis of the pleadings), it is clear that the Lohrs' allegations may include claims that Medtronic has, to the extent that they exist, violated FDA regulations. At least these claims, they suggest, can be maintained without being preempted by 360k, and we agree.  Nothing in 360k denies Florida the right to provide a traditional damages remedy for violations of commonlaw duties when those duties parallel federal requirements. Even if it may be necessary as a matter of Florida law to prove that those violations were the result of negligent conduct, or that they created an unreasonable hazard for users of the product, such additional elements of the statelaw cause of action would make the state requirements narrower, not broader, than the federal requirement. While such a narrower requirement might be different from the federal rules in a literal sense, such a difference would surely provide a strange reason for finding preemption of a state rule insofar as it duplicates the federal rule. The presence of a damages remedy does not amount to the additional or different requirement that is necessary under the statute; rather, it merely provides another reason for manufacturers to comply with identical existing requirements under federal law.  The FDA regulations interpreting the scope of 360k's preemptive effect support the Lohrs' view, and our interpretation of the preemption statute is substantially informed by those regulations. The different views expressed by the Courts of Appeals regarding the appro`"  Ԯpriate scope of federal preemption under 360k demonstrate that the language of that section is not entirely clear. In addition, Congress has given the FDA a unique role in determining the scope of 360k's preemptive effect. Unlike the statute construed in  J8 ԚCipollone, for instance, preemption under the MDA does not arise directly as a result of the enactment of the statute; rather, in most cases a state law will be preempted only to the extent that the FDA has promulgated a relevant federal requirement. Because the FDA is the federal agency to which Congress has delegated its authority to implement the provisions of the  J Act,  uB ԍ FTN  &  XFrXFr ddf < See n.5, supra; 21 U.S.C. 371(a). the agency is uniquely qualified to determine whether a particular form of state law stands as an obstacle to the accomplishment and execution of the full  J purposes and objectives of Congress, Hines v.  J ԚDavidowitz, 312 U.S. 52, 67 (1941), and, therefore, whether it should be preempted. For example, Congress explicitly delegated to the FDA the authority to exempt state regulations from the preemptive effect of the MDA"an authority that necessarily requires the FDA to assess the preemptive effect that the Act and its own regulations will have on state laws. See 360k(b). FDA regulations implementing that grant of authority establish a process by which States or other individuals may request an advisory opinion from the FDA regarding whether a particular state requirement is preempted by the statute. See 21 CFR 808.5 (1995). The ambiguity in the statute"and the congressional grant of authority to the agency on the matter  JP contained within it"provide a sound basis, post, at 2, for giving substantial weight to the agency's view of the  J statute. See Chevron U.S.A. Inc. v. Natural Resources  J Defense Council, Inc., 467 U.S. 837 (1984); HillsboroughG"    J Cty., 471 U.S., at 714 (considering FDA understanding of preemptive effect of its regulations dispositive).  The regulations promulgated by the FDA expressly support the conclusion that 360k does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act. 21 CFR 808.1(d)(2) (1995); see also  J Ԛ808.5(b)(1)(i).J uBP ԍ FTN  &  XFrXFr ddf < We also note that the agency permits manufacturers of devices that have received premarket approval to make certain labeling, quality control, and manufacturing changes which would enhance[] the safety of the device or the safety in the use of the device without prior FDA approval. See 21 CFR 814.39(d)(1) and (2) (1995). At this early stage in the litigation, there was no reason for the Court of Appeals to preclude altogether the Lohrs' manufacturing and labeling claims to the extent that they rest on claims that Medtronic negligently failed to comply with duties equal to, or substantially identical to, requirements imposed under federal law.  J  Manufacturing and Labeling Claims  !  Finally, the Lohrs suggest that with respect to the manufacturing and labeling claims, the Court of Appeals should have rejected Medtronic's preemption defense in full. The Court of Appeals believed that these claims would interfere with the consistent application of general federal regulations governing the labeling and manufacture of all medical devices, and therefore concluded that the claims were preempted altogether.  The requirements identified by the Court of Appeals include labeling regulations which require manufacturers of every medical device, with a few limited exceptions, to include with the device a label containing information for use, ... and any relevant hazards, contraindications, side effects, and precautions. 21"   CFR 801.109(b) and (c) (1995). Similarly, manufacturers are required to comply with Good Manufacturing Practices, or GMP's, which are set forth in 32 sections and less than 10 pages in the Code of Federal  J` Regulations.*` uB ԍ FTN  &  XFrXFr ddf < Some GMP's include the duty to institute a quality assurance program, 820.5, to have an adequate organizational structure, 820.20, to ensure that personnel in contact with a device are clean, healthy, and suitably attired where such matters are relevant to the device's safety, 820.25, and to have buildings, environmental controls, and equipment of a quality adequate to produce a safe product, see 820.40, 820.46, 820.60.* In certain circumstances, the Court of Appeals recognized, the FDA will enforce these general requirements against manufacturers that violate them. See 56 F.3d, at 1350!1351.  While admitting that these requirements exist, the Lohrs suggest that their general nature simply does not preempt claims alleging that the manufacturer failed to comply with other duties under state common law. In support of their claim, they note that 360k(a)(1) expressly states that a federal requirement must be applicable to the device in question before it has any preemptive effect. Because the labeling and manufacturing requirements are applicable to a host of different devices, they argue that they do not satisfy this condition. They further argue that because only state requirements with respect to a device may be preempted, and then only if the requirement relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device, section 360k(a) mandates preemption only where there is a conflict between a specific state requirement and a federal requirement applicable to the same device.  The Lohrs' theory is supported by the FDA regulations, which provide that state requirements are preempted only when the FDA has established specific"   counterpart regulations or ... other specific requirements applicable to a particular device. 21 CFR  J Ԛ808.1(d) (1995).  uB ԍ FTN  &  XFrXFr ddf < FDA's narrow understanding of the scope of 360k(a) is obvious from the full text of the regulation, which provides, in relevant part: (d) State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements. There are other State or local requirements that affect devices that are not preempted by section 521(a) of the act because they are not `requirements applicable to a device' within the meaning of section 521(a) of the act. The following are examples of State or local requirements that are not regarded as preempted by section 521 of the act:   (1) Section 521(a) does not preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices (e.g., requirements such as general electrical codes, and the Uniform Commercial Code (warranty of fitness)), or to unfair trade practices in which the requirements are not limited to devices.   (2) Section 521(a) does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act. <5 EllipsisXFrX @d P P %.tt..7.?.H.! ;5 Ellipsis!X @d XFr   (6)(i) Section 521(a) does not preempt State or local requirements respecting general enforcement, e.g., requirements that State inspection be permitted of factory records concerning all devices ....   (ii) Generally, section 521(a) does not preempt a State or local requirement prohibiting the manufacture of adulterated or misbranded devices. Where, however, such a prohibition has the effect of establishing a substantive requirement for a specific device, e.g., a specific labeling requirement, then the prohibition [may] be preempted. 21 CFR 808.1(d) (1995). They further note that the statute is not intended to preempt State or local requirements of general applicability where the purpose of the requirement relates either to other products in addition to devices ... or to unfair trade practices in which the'"   requirements are not limited to devices. 808.1(d)(1). The regulations specifically provide, as examples of permissible general requirements, that general electrical codes and the Uniform Commercial Code warranty of  J` fitness would not be preempted. See ibid. The regulations even go so far as to state that 360k(a) generally does not preempt a state or local requirement prohibiting the manufacture of adulterated or misbranded devices unless such a prohibition has the effect of establishing a substantive requirement for a specific device. 808.1(d)(6)(ii). Furthermore, under its authority to grant exemptions to the preemptive effect of 360k(a), the FDA has never granted, nor, to the best of our knowledge, even been asked to consider granting, an exemption for a state law of general applicability; all 22 existing exemptions apply to excruciatingly specific state requirements regarding the sale of hearing aids. See 808.53!808.101.  Although we do not believe that this statutory and regulatory language necessarily precludes general federal requirements from ever preempting state requirements, or general state requirements from ever  J being preempted, see Part VI, infra, it is impossible to ignore its overarching concern that preemption occur only where a particular state requirement threatens to interfere with a specific federal interest. State requirements must be with respect to medical devices and different from, or in addition to federal requirements. State requirements must also relate to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device, and the regulations provide that state requirements of general applicability are not preempted except where they have the effect of establishing a substantive requirement for a specific device. Moreover, federal requirements must be applicable to the device in question, and, according to the regulations, preempt state law`"   only if they are specific counterpart regulations or specific to a particular device. The statute and regulations, therefore, require a careful comparison between the allegedly preempting federal requirement and the allegedly preempted state requirement to determine whether they fall within the intended preemptive  J scope of the statute and regulations.L uBx ԍ FTN  &  XFrXFr ddf < A plurality of this Court concluded in Cipollone that a similar analysis was required under the Public Health Cigarette Smoking Act of 1969. That act preempted requirements and prohibitions based on smoking and health imposed under State law with respect to the advertising or promotion of cigarettes in packages that were labeled in conformity with the that act. 505 U.S., at 515. We held that the petitioner's fraudulent misrepresentation claims, including those based on allegedly false statements made in advertisements, were not preempted because they were predicated not on a duty `based on smoking and health' but rather on a more general obliga uB tion"the duty not to deceive. Id., at 528!529. The general commonlaw duty not to make fraudulent statements was not within the specific category of requirements or prohibitions based on smoking and health imposed under State law with respect to the advertising or promotion of cigarettes that were preempted by the  uB1 1969 statute. Id., at 529.  If anything, the language of the MDA's preemption statute and its counterpart regulations require an even more searching inquiry into the relationship between the federal requirement and the state  uB  requirement at issue than was true under the statute in Cipollone.  Such a comparison mandates a conclusion that the Lohrs' commonlaw claims are not preempted by the federal labeling and manufacturing requirements. The generality of those requirements make this quite unlike a case in which the Federal Government has weighed the competing interests relevant to the particular requirement in question, reached an unambiguous conclusion about how those competing considerations should be resolved in a particular case or set of cases, and implemented that conclusion via a specific mandate on manufacturers or producers. Rather, the federalX"   requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements.  Similarly, the general state commonlaw requirements in this case were not specifically developed with respect to medical devices. Accordingly, they are not the kinds of requirements that Congress and the FDA feared would impede the ability of federal regulators to implement and enforce specific federal requirements. The legal duty that is the predicate for the Lohrs' negligent manufacturing claim is the general duty of every manufacturer to use due care to avoid foreseeable dangers in its products. Similarly, the predicate for the failure to warn claim is the general duty to inform users and purchasers of potentially dangerous items of the risks involved in their use. These general obligations are no more a threat to federal requirements than would be a statelaw duty to comply with local fire prevention regulations and zoning codes, or to use due care in the training and supervision of a workforce. These state requirements therefore escape preemption, not because the source of the duty is a judgemade commonlaw rule, but rather because their generality leaves them outside the category of requirements that 360k envisioned to be with respect to specific devices such as pacemakers. As a result, none of the Lohrs' claims based on allegedly defective manufacturing or labeling are preempted by the MDA.  9H1 d d7VI؃  Jd  d2   FTN    XFrXFr ff In their crosspetition, the Lohrs present a final argument, suggesting that commonlaw duties are never requirements within the meaning of 360k and that the statute therefore never preempts commonlaw actions. "    J The Lohrs point out that our holding in Cipollone is not  J dispositive of this issue, for as Part IV, supra, suggests, there are significant textual and historical differences  J between the Cipollone statute and 360k, and the meaning of words must always be informed by the environment within which they are situated. We do not think that the issue is resolved by the FDA regulation suggesting that 360k is applicable to those requirements having the force and effect of law that are established by ... court decision, 21 CFR 808.1(b) (1995); that reference, it appears, was intended to refer to court  JH decisions construing state statutes or regulations. See 42 Fed. Reg. 30383, 30385 (June 14, 1977); Brief for Petitioners in No. 95!886, at 26, n.7.  Nevertheless, we do not respond directly to this argument for two reasons. First, since none of the Lohrs' claims is preempted in this case, we need not resolve hypothetical cases that may arise in the future. Second, given the critical importance of devicespecificity in our (and the FDA's) construction of 360k, it is apparent that few, if any, commonlaw duties have been preempted by this statute. It will be rare indeed for a court hearing a commonlaw cause of action to issue a decree that has the effect of establishing a substantive requirement for a specific device. 21 CFR 808.1(d)(6)(ii) (1995). Until such a case arises, we see no need to determine whether the statute explicitly preempts such a claim. Even then, the issue may not need to be resolved if the claim would also be preempted  Jx under conflict preemption analysis, see Freightliner  JP Corp. v. Myrick, 514 U.S. ___, ___ (1995) (slip op., at 7!8).  9H1 d d\7VII؃  <2  Accordingly, the judgment of the Court of Appeals is reversed insofar as it held that any of the claims were preempted and affirmed insofar as it rejected the pre"  ԫemption defense. The case is remanded for further proceedings.  J ` BIt is so ordered.