Legal Document

518 U.S. 470116 S.Ct. 2240135 L.Ed.2d 700 MEDTRONIC, INC., Petitioner,v.Lora LOHR, et vir. Lora vir, Petitioners, v. INC. Nos. 95-754, 95-886. Supreme Court of the United States Argued April 23, 1996. Decided June 26, 1996.* Syllabus** Enacted ''to provide for safety and effectiveness medical devices intended human use,'' Medical Device Amendments 1976 (MDA or Act) classifies such based on risk that they pose to public. Class III greatest and, thus, are subject a rigorous premarket approval (PMA) process. However, most market have not been through PMA process due two statutory exceptions. Realizing existing could be withdrawn from while Food Drug Administration (FDA) completed analyses, Congress included provision allowing pre-1976 remain without FDA until requisite is completed. The Act also permits ''substantially equivalent'' pre-existing avoid initiates underlying device. uses ''premarket notification'' submitted by all manufacturers (B 510(k) process) determine substantial equivalence devices. Petitioner Medtronic, Inc.'s pacemaker device found substantially equivalent under § Cross-petitioners Lohrs filed Florida state-court suit alleging both negligence strict liability claims in failure her Medtronic pacemaker, but removed case Federal District Court. That court ultimately dismissed complaint as having pre-empted 21 U.S.C. 360k(a), which provides ''no State politic al subdivision may establish continue effect with respect use any requirement (1) different from, addition to, applicable [the MDA] device, (2) relates other matter Act].'' Appeals reversed part affirmed part, concluding Lohrs' negligent design were pre-empted, their manufacturing warn were. Held: judgment remanded. 56 F. 3d 1335, 1 Justice STEVENS delivered opinion Parts I, II, III, V, VII, MDA does pre-empt common-law claims. Pp. ___-___; ___. 2 (a) While need go beyond 360k(a)'s pre-emptive language whether at least some state law, see Cipollone Liggett Group, Inc., 505 504, 517, 112 2608, 2618, 120 407, ''the domain expressly pre-empted'' must identified. Ibid. Interpretation text informed assumptions States' historic police powers cannot superseded unless Congress' clear manifest purpose, Rice Santa Fe Elevator Corp., 331 218, 230, 67 1146, 1152, 91 L.Ed. 1447, understanding pre-emption statute's scope rests primarily ''a fair congressional '' Cipollone, U.S., 530, n. 27, S.Ct., 2624, 27. ___-___. 3 (b) pre-empted. FDA's determination well its continuing authority exclude do amount specific, federally enforceable affected state-law pressures those imposed here. Since focused equivalence, safety, determinations little protection Neither scheme nor legislative history suggests was anything than maintain status quo, possibility device's manufacturer would defend itself against ___-___ 4 (c) Section 360k(a) rules merely duplicate regulating practices labeling. requirements narrower federal make them ''different'' 360k. Nor presence damages remedy an additional ''requirement''; it another reason comply identical law ''requirements.'' This view supported regulations FDA, has delegated implement MDA. 5 (d) labeling Although regulatory preclude ''general'' ever pre-empting requirements, being impossible ignore overarching concern occur only where particular threatens interfere specific interest. ''with to'' ''different requirements. They relate device,'' general applicability establishing substantive device.'' ''applicable device'' question, according regulations, if ''specific counterpart regulations'' ''specific'' ''particular issue reflect important entirely generic concerns about regulation generally, sort regarding field statute designed protect potentially contradictory Similarly, Florida's specifically developed kinds feared impede implementation enforcement 6 STEVENS, joined KENNEDY, SOUTER, GINSBURG, concluded Part IV Medtronic's argument cause action ''requirement'' implausible, grant complete immunity defect entire industry that, judgment, needed more stringent regulation. It take much plainer 360k's that. word ''requirement,'' appears presume imposing duty upon manufacturer, odd term indicate sweeping urges 521-522, 2620, distinguished. legislation's basic purpose support rejection extreme position. 7 BREYER although will sometimes tort suit, First, since MDA's highly ambiguous, courts look elsewhere help just how might so. Second, absence command pre-emption, infer relevant administrative agency possesses degree leeway rules, actions effect. See Hillsborough County Automated Laboratories, 471 707, 721, 105 2371, 2379, 85 714. Third, consider Fourth, ordinary principles ''conflict'' ''field'' conclusion plaintiffs' 8 J., announced BREYER, JJ., joined, VI, joined. REHNQUIST, C. O'CONNOR, SCALIA, THOMAS, part. concurring judgment. dissenting SCALIA 9 Arthur R. Miller, Inc. 10 Brian Wolfman, Washington, DC, Lohr, vir.AT1SEdwin S. Kneedler, amicus curiae, special leave 11 GINSBURG join. 12 enacted 1976, words preamble, medica l use.'' 90 Stat. 539. question presented pre-empts allegedly defective Specifically, we who injured when failed, rely common recover 13 * Throughout our several exercised health citizens. Because these ''primarily, historically, . matter[s] local concern,'' 719, 2378, 714 (1985), ''States traditionally had great latitude legislate lives, limbs, health, comfort, quiet persons.'' Metropolitan Life Ins. Co. Massachusetts, 724, 756, 2380, 2398, 728 (1985) (internal quotation marks omitted). 14 Despite prominence matters public recent decades Government played increasingly significant role people. first enactment 1906, broad prohibition manufacture shipment interstate commerce adulterated misbranded food drug. 34 768; Regier, Struggle Drugs Legislation, Law. & Contemp. Probs. (1933). Partly response ongoing radio newspaper advertising making false therapeutic ''quack machines'' legitimate surgical instruments orthopedic shoes, 1938 broadened coverage 1906 include cosmetics. Food, Drug, Cosmetic (FDCA), §§ 501, 502, 52 1049-1051; Cavers, 1938: Its Legislative History Substantive Provisions, (1939); H.R.Rep. No. 94-853, p. (1976). 15 FDCA provided pre-market new drugs, Probs., 40, did authorize control over introduction devices, S.Rep. 93-670, pp. 1-2 (1974); H.R. Rep. 6. As technologies advanced medicine relied increasing vast array equipment ''[f]rom bedpans brainscans,''1 including kidney dialysis units, artificial heart valves, pacemakers,2 policymakers became concerned severe injuries resulted generally Finck, Effectiveness Regulation, U.C.D.L.Rev. 293, 297-301 7. 16 In 1970, example, Dalkon Shield, intrauterine contraceptive introduced American throughout world. Touted safe effective contraceptive, Shield disturbingly high percentage inadvertent pregnancies, serious infections, even, few cases, death. Id., 8; Regulation Devices (Intrauterine Contraceptive Devices), Hearings before Subcommittee House Committee Operations, 93rd Cong., 1st Sess. (1973). early 1970's, catheters, defibrillators, pacemakers (including manufactured petitioner Medtronic), attracted attention consumers, possible risks. Dev ice Amendments, 1973, Health Senate Labor Public Welfare, 2d Sess., 270-361 17 mounting consumer concern, here: Act), three categories present no unreasonable illness injury designated I minimal ''general controls.'' 360c(a)(1)(A). harmful II; marketed advance approval, performance known ''special 360c(a)(1)(B). Finally, either ''present potential injury,'' ''purported represented supporting sustaining life importance preventing impairment health,'' III. 360c(a)(1)(C). Pacemakers CFR 870.3610 (1995). 18 Before market, ''reasonable assurance'' effective. 360e(d)(2). relatively innocuous phrasing, this assurance,'' approval,'' ''PMA'' process, one. Manufacturers submit detailed information efficacy then reviews, spending average 1,200 hours each submission. Environment Energy Commerce, 100th (Ser. 100-34), 384 (1987) (hereinafter 1987 Hearings); Kahan, Premarket Approval Versus Notification: Different Routes Same Market, 39 Cosm. L.J. 510, 512-514 (1984). 19 Not all, even most, today received because exceptions requirement. realized analysis therefore includes ''grandfathering'' allows time completes PMA. 360e(b)(1)(A); 814.1(c)(1).3 prevent grandfathered monopolizing hurdle, ensure improvements can rapidly into 360e(b)(1)(B). 20 review, II 360(k). section imposes limited form review every intending requiring (the process,'' after number origina Act). If concludes basis notification further (at equivalent''). means comparable process; contrast necessary hours. Hearings, 384. one commentator noted, ''[t]he attraction clear. [Section] requires information, rarely elicits negative gets processed very quickly.'' Adler, Amendments: A Step Right Direction Needs Another Direction, 43 511, 516 (1988); L. 514-519. anticipated swiftly. But investment energy resolution application, ever-increasing numbers internal resource difficulties, simply keep up result, devices--including devices--were approved market. 1983, instance, Report nearly 1,000 approximately 1,100 admitted ''substantial equivalents'' review. Regulation: Neglected Child (Committee Print compiled Oversight Investigations Commerce), Comm. 98-F, (1983). lopsidedness apparently evened out; despite effort reported 1990 80% 101-808, (1990); D. Kessler, Pape, Sundwall, Devices, 317 New England J. Med. 357, 359 (55 notifications application; one-fifth PMA).4 22 so many manufacturers, took advantage 510(k)'s expedited October 1982, notified Model 4011 lead already (The portion transmits heartbeat-steadying electrical signal ''pulse generator'' itself.) On November 30, model commerce'' prior date Act, advised provisions Code Regulations. Respondent's Memorandum Support Motion Summary Judgment 93-482 (MD Fla., Nov. 1, 1993), Exh. (Declaration Charles H. Swanson) Substantial Equivalence Letter). emphasized, however, should construed endorsement pacemak er lead's safety. 23 Cross-petitioner Lohr dependent technology proper functioning heart. she implanted equipped company's leads. December 1990, resulting ''complete block'' required emergency surgery. According physician, likely failure. 24 1993 husband court. Their contained count count. alleged breach ''duty reasonable care design, manufacture, assembly, sale pacemaker'' respects, materials properly instruct plaintiff physicians tendency fail, knowledge earlier failures. Complaint ¶57 5. condition unreasonably dangerous foreseeable users sale. ¶ 11. ( third warranty claim law.) 25 Court, motion summary arguing 360k(a). section, core dispute between parties case, provides: 26 ''B respecting 27 ''(a) General rule 28 ''Except subsection political requirement-- 29 ''(1) chapter 30 ''(2) chapter.''5 31 initially denied motion, finding thing exempted violated regulations. App. Pet. Cert. 5d. long decision, Eleventh Circuit 360k brought Duncan Iolab F.3d 194 (1994). After reconsidering ruling light Duncan, decision complaint. 32 1335 (C.A.11 1995). Rejecting broadest submission, decided ''common within meaning 360k(a).'' 1342. next held avoided flowed violation standards. 1343. Then, ''requirements'' unclear, sought guidance pre-emption. Those established 'specific device.' 1344 (citing 808.1(d) (1995)). Under concluded, deal pacemakers, ''should, way, 'restricted nature' procedure, completely open-ended,'' F.3d, 1346, 33 approach, rejected equivalence'' significance pacemaker's continued surveillance constituted maintained. 1347-1349. hand, ''good practices'' steps id., 1350; 820.20-820.198 (1995), require bear various warnings, 1350-1351, 801.109 made parallel disposition claims, holding there insofar plaintiffs revive theory. 1351-1352. petition certiorari seeking Appeals' cross-petition upheld defense. Courts divided extent MDA,6 granted petitions. ----, 116 806, 133 752 (1996). 35 407 (1992), task interpreting law. nonetheless ''identify language. begin text, Gade National Solid Wastes Management Assn., 88, 111, 2374, 2389-2390, 73 (1992) (KENNEDY, judgment), interpretation contextual vacuum. Rather, presumptions nature ibid. 36 independent sovereigns system, presumed cavalierly causes action. particularly ''legislated occupied,'' 1447 (1947), ''start assumption Congress.'' 1152; Cty., 715-716, 2376; cf. Fort Halifax Packing Coyne, 482 22, 107 2211, 2223, 96 (1987). Justices argued apply opposed questions concerning invalidation 545-546, 2632-2633 (SCALIA, part), used ''presumption power narrow express Cipollone. 518, 523, 2621. approach consistent federalism primacy 37 guided oft-repeated comment, Retail Clerks Schermerhorn, 375 96, 103, 84 219, 222, 179 (1963), ultimate touchstone'' case. See, e.g., 516, 2617; Gade, 2381-2382; Malone White Motor 435 497, 98 1185, 1190, 55 443 (1978). rest purpose. (opinion J.). intent, course, discerned ''statutory framework'' surrounding it. 2390 judgment). Also relevant, ''structure whole,'' 98, 2383 J.), revealed reviewing court's reasoned way affect business, 38 With considerations mind, turn consideration Appea ls merits cross-petition. petition, argues erred chapter.'' alters incentives duties standards promulgated mandates essence, company plain 40 unpersuasive, implausible. statute, effectively precluded affording consumers Moreover, explicit private MDA, suggestion created implied right action, barred relief persons devices.7 construction perverse granting Congress, order 539 (preamble is, say least, ''difficult believe would, remove judicial recourse illegal conduct,'' Silkwood Kerr-McGee 464 238, 251, 104 615, 623, 78 (1984), convince us result. 41 Furthermore, chose singularly achieved ''remedy'' relating ''Requirement'' occasions certain 2620 sweep broadly does. 42 Cipollone8 targeted set requirements--those ''based smoking health''--and subset applications involving ''advertising promotion cigarettes packages labeled conformity of'' statute. id. , 515, 2617. context, giving widest remedies reading able using theories run afoul 524-530, 2621-2624. Here, far greater interference legal remedies, producing intrusion sovereignty simultaneously wiping out injuries.9 Given ambiguities preclusion otherwise, accept clearly signaled intent deprive protecting dangers inherent Other differences 360k, problem conflicting statutes rather enforced actions. Unlike refers times text. linked suggesting focus device-specific enactments positive bodies, application judges juries. For subsections (a)(2) statute10 refer ''requirements''--but exists pursuant itself, given Of ''exemptions'' granted, none remotely resemble claims.11 44 An examination legislation supports asserts intended, ''protect innovations 'stifled unnecessary restrictions,' Brief Petitioners 12), interest extended certainly reflects concerns,12 indicates fears burdens related danger preexisting 122 Cong. Rec. 5850 (Mar. 9, 1976) (statement Collins) (opposing ''redundant burdensome requirements''); 5855 (discussing efforts taken small businesses Indeed, nowhere Act's discovered reference fear product hamper development To industry, manifested fewer provision; furthermore, outweighed primary motivating enactment: 45 confirms 360(k) let alone There best knowledge, nothing hearings, committee reports, debates proponent traditional distributors hint spectacularly odd, Members Houses acutely aware litigation.13 Along less-than-precise silence surely maintained V 46 reasons why, con trast, argue survive evaluation correctly pacemaker. suggest State's impose conflict Design Claim 47 sufficiently concrete constitute counters pointing agency's changed. These factors, argues, suits. 48 defense exaggerates letter below safety.'' 1348. compare post-1976 ascertain later less poses ineffective, risky ineffective.'' 516. 4011, never formally reviewed efficacy. 49 stressed standards''--the lowest level devices,'' ''listing good practices, labeling, misbranding adulteration Act.'' explicitly warned ''not denote official your ''[a]ny representation creates impression complianc e misleading constitutes misbranding.'' Letter. 50 Thus, though examine (as examines industry) 22-26, ''require'' Medtronics' reason; allowed existed running gauntlet providing exemption give freedom compete, degree, same terms 1976.14 quo marketing equivalents. design. background behind exemption, fact 2617 citations omitted), presumption Identity Requirements Claims 51 exist to,'' 360k(a)(1). precise contours theory recovery yet defined pleadings), allegations has, exist, At suggest, agree. Nothing denies violations Even prove result conduct, hazard product, elements narrower, broader, from'' literal sense, difference sure ly strange duplicates rule. statute; rather, 53 view, views expressed appropriate demonstrate addition, unique determining arise directly cases ''requirement.'' Act,15 uniquely qualified ''stands obstacle accomplishment execution full purposes objectives Congress,'' Hines Davidowitz, 312 52, 67, 61 399, 404, 581 (1941), therefore, exempt MDA--an necessarily assess own laws. 360k(b). implementing individuals request advisory 808.5 ambiguity statute--and it--provide ''sound basis,'' post, __, weight Chevron U.S.A. Natural Resources Defense Council, 467 837, 2778, 81 694 (1984); 714, 2375-2376 (considering ''dispositive''). 54 ''does preempt equal act.'' 808.1(d)(2) (1995); 808.5(b)(1)(i).16 stage litigation, altogether negligently failed ''equal imposed'' full. believed governing lab eling altogether. identified exceptions, label containing ''information use, hazards, contraindications, side effects, precautions.'' 801.109(b) ''Good Manufacturing Practices,'' ''GMP's,'' forth sections pages Regulations.17 circumstances, recognized, enforce violate them. 1350-1351. 57 admitting claim, note 360k(a)(1) states host satisfy condition. ''relates 58 ''only'' (1995).18 ''State products unfair trade devices.'' 808.1(d)(1). provide, examples permissible codes Uniform Commercial fitness prohibiting devices'' ''such 808.1(d)(6)(ii). exemptions nor, asked granting, applicability; excruciatingly hearing aids. 808.53-808.101. 59 precludes infra, applicability'' except careful comparison fall regulations.19 60 Such generality quite unlike weighed competing interests reached unambiguous resolved implemented via mandate producers. Accordingly, ability regulators predicate products. inform purchasers items risks involved use. obligations threat fire prevention zoning codes, training supervision workforce. escape source judge-made rule, leaves outside category envisioned pacemakers. VI 62 cross-petition, final argument, point dispositive issue, IV, supra, suggests, textual historical always environment situated. We think ''having force law'' ''established decision,'' 808.1(b) reference, appears, decisions construing Fed.Reg. 30383, 30385 (June 14, 1977); 95-886, 63 Nevertheless, respond reasons. resolve hypothetical future. critical device-specificity (and FDA's) apparent few, any, rare indeed decree 808.1(d)(6)(ii) Until arises, claim. then, analysis, Freightliner Corp. Myrick, 514 115 1483, 1488, 131 385 VII 64 remanded proceedings. 65 ordered. 66 raises questions. (MDA) Cosmetics action? so, here? 68 My answer suit. basically agree O'CONNOR's discussion conclusion. __-__. language, read literally, says:SU11S''[N]o [state] [federal] (emphasis added).DCSOne reasonably grow 69 similar ''easily'' encompassed ''[state] exerted award preventive relief.'' 521, (plurality opinion) omitted); 548-549, 2634 part). Accord CSX Transp. Easterwood, 507 658, 664, 113 1732, 1737-38, 123 387 (1993). rationale seem circumstances 70 contrary anomalous consequences. Imagine aid component, 2-inch wire, 1-inch wire. embodied ''2-inch'' regulation, ''1-inch'' why similarly premises defendant manufacturer's wire (say, jury persuaded expert testimony negligent)? effects identical. distinguish (to standards) single officials acting lawmaking processes. Where matter, ante, __-__, 71 Consequently, ordinarily, takes standard behavior state-l aw plurality agrees point, explicitly. 72 second turns intent. Barnett Bank Marion N.A. Nelson, 517 1103, 1107-1108, 134 237 (1996); Allis-Chalmers Lueck, 202, 208, 1904, 1909-1910, 206 (1985); __. stated does, not, here me conclude not. ambiguous. makes says when, where, how, ''any requirement'' requirement,'' tell requirement; yet, existence say, packaging shipping 74 previously suggested Smiley Citibank (South Dakota), N. A., 1730, 1733, --- ---- Lawrence Lead-Deadwood School Dist. 40-1, 469 256, 261-262, 695, 698-699, 83 635 842-845, 2781-2783, draw inference ambiguity. fully responsible administering 393. responsibility involvement impact (or which) objectives. Hillsborough, 2379. translate understandings particularized intentions accompanying 718, 2377-2378. communicate intentions, statements ''regulations, preambles, interpretive statements, responses comments,'' ibid., exercise 360k(b); __-__ (noting laws' effect). 75 help. says:SU21S''State preempted thereby divergent requirements.'' (1995) added). 76 fill gaps, ''divergent'' explain, device-related closely enough trigger analysis. regulation's universe intends displace 77 Insofar here, numerous, sense. Hence, above-quoted tells us, intend forces appropriate. characterization ''comprehensive'' ''extensive,'' questionable, said ''seldom infer, solely comprehensiveness entirety 2377. seems better indicator pre-emption-related And practical circumstance agency. 79 direction. actually conflicts requirement--either compliance impossible, Lime Avocado Growers, Paul, 373 132, 142-143, 1210, 1217-1218, 248 (1941)--or ''so pervasive left room supplement it,'' (1947). Bank, 1107-1108; 2383, J.); Wisconsin Intervenor Mortier, 501 597, 604-605, 111 2476, 2481-2482, 532 (1991); English Elec. Co., 496 72, 79, 110 2270, 2275, (1990). 80 indication agency) regulation) principles. ''in readily lend themselves reading, parallels law's concerns. Without agency, interpret find actual liability-creating-premises suit; discussed above, oc cupy field. 82 reasons, concur Court's join opinion, VI. emphasizes my am convinced future incidents ''few'' ''rare,'' whom THE CHIEF JUSTICE, THOMAS join, (MDA), ''which (FDCA) points out, provision, ''we pre-empt'' Ante, agree, us: accordance terms. This, do. differ FDCA. acknowledges ''rare indeed.'' reach determination, opinion--without relying offering sound deference warranted--imports ''inform'' reading. principal occurs ''where interest,'' reason, almost bewildering seemingly guiding principle. 86 demonstrates raised connection lead. Analysis, 87 recently addressed examined phrase prohibition'' Cigarette Smoking 1969. (1992). majority agreed opinion), explained: 88 ''The phrase, '[n]o prohibition' sweeps distinction law; contrary, easily encompass rules. noted '[state] relief. obligation pay compensation be, potent method conduct contro lling policy.' San Diego Building Trades Council Garmon, 236, 247, 773, 780-781, 775 (1959).'' 2620. 89 equally context. Whether operate duties. declared, odds words'' actions.'' meaning, FDCA--just reaches plurality's departing neither persuasive. fails refute reasoning Instead, essentially history, consequences interpretation, all. proceeds disclaim position, concludes, requirement, holds triggers __ (''[W]e 'general' '') ''critical device-specificity'' scheme. imports put relies arrive Apparently recognizing unwarranted admit deferring ''infor[m]'' interpretation. entitled deference, N.A., 1734, pertaining ''If contains clause, instance wording evidence intent.'' Transp., 1737, clear, resort improper. 842-843, 2781-2782, Title directs FDCA] explained agrees, encompasses comm on-law errs employs narrowing warranted. mention specificity, restriction exists. 92 states, recognition From premise, proceed 93 FDCA's equivalency'' evaluates Amendments; marketed. seeks equivalent, places 94 seek sure, comply, differ. 95 disagree, compel subscribe ''specificity,'' what broader. Some FDA. Good Practice (GMP) comprehensive aspect device-manufacturing organization personnel, buildings, equipment, component controls, production holding, distribution, installation, evaluation, record keeping. successful, GMP fashion, failure-to-warn extensive (requiring labels indications, routes, methods, frequency duration administration, precautions). Medtronic. specificity summarize, ''specific,'' affirm pre-empted; reverse Together vir ** syllabus prepared Reporter Decisions convenience reader. Detroit Lumber 200 321, 337, 282, 287, 499. 94-33, (1975). initiated initiation 41984, 41986 (pursuant Safe 4511, calling submission February 1997 reclassify initiate implantable pulse generators adapters). amendments reduce reliance 1990. Subsection authorizes otherwise (a). 360k(b) ''(b) Exempt ''Upon thereof, Secretary may, notice opportunity oral hearing, conditions prescribed if-- subsection; ''(A) compelling conditions, ''(B) carry authority, issued construe address instances 808.1 18. exercises gives Human Services, subsequently (''the may'' requirements), 321(d) (''Secretary'' Services''). FDCA, vested promulgate efficient Act. 371(a). Mentor 477 (C.A.3 1995) ''requirements''); Feldt 431 (C.A.5 create Michael Shiley 1316 (claim pre-empted); (case below) requirements; covered 360k(a)); Kennedy Collagen 1453 (C.A.9 (common-law 360k(a)). recall, replace, refund plaintiffs, available parties, extend compensatory damages, invoked, 526-527 (1988). issue: first, 1965, ''[n]o statement shall required'' cigarette package advertising. 514, 2616. petitioner's 518-520, 2618-2619. 1969, 1965 bulk Cipollone's stated, subsequent references issuance territory exclusively occupied itself; specified warning smokers deemed sufficient. specifics (reliance warranted, inter alia, administration 360k). broader predecessor. 520-521, 2616-2617, 2619-2620. quoted All 808.53-808.101 Special exemptions, permit (with oversight provisions) allow investigative, experimental equivalence.'' 360j(g); pt. 813 unduly work dramatic change availability expect contemporary reviews legislation. reference. Lesparre, Industry Spokesman Comments Hospitals 99, 103 (Sept. 16, 1976); A. Levine, Failure Plaintiff's Lawyer, Proceedings Second Annual AAMI/FDA Conference (1975); 1975, Interstate Foreign Ser. 94-39, 94th C ong., 271 (1975) Anita Johnson, Citizen's Research Group) (arguing included, discussing California devices); Equipment Liability Avoidance (Frost Sullivan pub. 1977) (comprehensive 2--volume, 600--page published 1910 mooted altered longstanding receive awards law). Commissioner procompetition mechanism firms quickly me-too versions firm whose happened preclearance enjoy lengthy monopoly expense consumer.'' Oversight: Hearing 97th (1982). 514-515 5, supra; quality control, changes ''enhance[ ] approval. 814.39(d)(1) (1995).PHSManufacturing Labeling GMP's institute ''quality assurance program,'' 820.5, ''adequate organizational structure,'' 820.20, personnel contact ''clean, healthy, suitably attired'' 820.25, environmental adequate produce 820.40, 820.46, 820.60. obvious provides, part: ''(d) act, 521(a) act 'requirements device' act. following regarded 521 act: (e.g., (warranty fitness)), ''(6)(i) enforcement, inspection permitted factory records ''(ii) Generally, Where, [may] preempted.'' prohibitions ''imposed promotion'' fraudulent misrepresentation advertisements, ''predicated 'based health' obligation--the deceive.'' 528-529, 2623-2624. statements'' 1969 529, 2624.FC21SIf anything, searching inquiry relationship true

Classification Label: 9