Medical device regulation in the United States and the European Union: A comparative study

Food and Drug Law Journal

Volumn 55, Issue 1, 2000, Pages 57-80

  Chai, John Y ^a  

^a NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLASSIFICATION; EUROPE; FOOD AND DRUG ADMINISTRATION; INTERNATIONAL COOPERATION; LAW; MARKETING; MEDICAL INSTRUMENTATION; QUALITY CONTROL; REGULATORY MECHANISM; REVIEW; STANDARD; UNITED STATES;

DEVICE APPROVAL; EFFICIENCY, ORGANIZATIONAL; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; EUROPEAN UNION; HUMANS; INTERNATIONAL COOPERATION; LEGISLATION, MEDICAL; MARKETING OF HEALTH SERVICES; PRODUCT SURVEILLANCE, POSTMARKETING; PUBLIC HEALTH; QUALITY CONTROL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0034001519     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (235)

1. Health Industry Manufacturers Association, U.S. Medical Technology Industry Fact Sheet (visited Jan. 5, 1999) 〈www.himanet.com/publicdocs/98factsheet.htm〉.
2. Id.
3. 21 U.S.C. § 360(c) (1994).
4. 61 Fed. Reg. 52,602 (Oct. 7, 1996) (codified at 21 C.F.R. pt. 820 (1996)).
5. 21 U.S.C. § 360(f); Medical Device Recall Authority, 21 C.F.R. pt. 810 (1998).
6. Food and Drug Administration Modernization Act of 1997 (FDAMA), Pub. L. No. 105-115, 111 Stat. 2296; 60 Fed. Reg. 63,578 (Dec. 11, 1995).
7. 21 U.S.C. § 334.
8. Id. § 332; Medical Device Corrections and Removals, 21 C.F.R. pt. 806.
9. 21 C.F.R. pt. 5.10.
10. 21 U.S.C. § 360(f); Banned Devices, 21 C.F.R. pt. 895.
11. 21 C.F.R. pt. 5.55.
12. 21 U.S.C. § 360(f).
13. Id.; 21 C.F.R. pt. 17.
14. 63 Fed. Reg. 63,222 (Nov. 12, 1998). A premarket notification or premarket notification submission commonly is known as a 510(k). Excluding 510(k)-exempt Class I and II devices, all post-amendment devices are classified automatically into Class III and require premarket approval unless or until FDA approves the petition for reclassification of a device into Class I or II, or FDA finds a post-amendment device substantially equivalent to a legally marketed device that does not itself require premarket approval. Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (codified in scattered sections of 21 U.S.C. (1994)). The Medical Device Amendment provided that a device that was "not introduced or delivered for introduction into interstate commerce . . . before the date of the enactment of the Act" was classified automatically in Class III unless it is substantially equivalent to either an existing device or a post-enactment Class I or Class II device.
15. 21 U.S.C. § 360(c).
16. Id.
17. Id. § 360(d). By issuing guidance documents that reference voluntary standards, FDA avoided the onerous process required for promulgation of mandatory standards.
18. Id. § 360(j).
19. 63 Fed. Reg. at 59,222.
20. 21 U.S.C. § 360(c).
21. Id. § 360.
22. Id.
23. Id. § 360(e).
24. See, e.g., 64 Fed. Reg. 12,774 (Mar. 15, 1999).
25. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., The New 510(k)Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance 3 (last modified Mar. 8, 1998); CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., Reengineering - Year I Accomplishments & Future Plans 286 (last modified Apr. 17, 1998) 〈www.fda.gov/cdrh/reenging/ otannrep.html〉 [hereinafter Reengineering Accomplishments].
26. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., The New 510(k)Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance 3 (last modified Mar. 8, 1998); CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., Reengineering -Year I Accomplishments & Future Plans 286 (last modified Apr. 17, 1998) 〈www.fda.gov/cdrh/reenging/ otannrep.html〉 [hereinafter Reengineering Accomplishments].
27. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., The New 510(k)Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance 3 (last modified Mar. 8, 1998); CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., Reengineering - Year I Accomplishments & Future Plans 286 (last modified Apr. 17, 1998) 〈www.fda.gov/cdrh/reenging/ otannrep.html〉 [hereinafter Reengineering Accomplishments].
28. 21 U.S.C. §§ 360(i), (1).
29. Council Directive 93/42/EEC, 1993 O.J. (L 169) 3.
30. Id. art. 9; Council Directive 98/79/EC, art. 9, 1998 O.J. (L 331).
31. Council Directive 93/42/EEC on Medical Devices, Annex VII, 1993 O.J. (L 169); Council Directive 98/79/EC In Vitro Diagnostic Medical Devices, Annex III, 1998 O.J. (L 331); Class I devices that must be marketed in a sterile condition or perform measurement functions are subject to additional limited Quality Assurance System requirements. Council Directive 93/42/EEC, Annex VII.5, 1993 O.J. (L 169).
32. Council Directive 98/79/EC, art. 9, 1998 O.J. (L 331).
33. Id.
34. Id. art. 8.
35. Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. at 539.
36. Pub. L. No. 75-717, 52 Stat. 1040 (codified as amended at 21 U.S.C. §§ 301-393).
37. Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. at 539.
38. Safe Medical Devices Act, Pub. L. No. 101-629, 104 Stat. 4511 (1990).
39. FDAMA of 1997, Pub. L. No. 105-115, 111 Stat. at 2296.
40. See, e.g., STAFF OF HOUSE SUBCOMM. ON OVERSIGHT & INVESTIGATIONS OF THE HOUSE COMM. ON ENERGY & COMMERCE, 98TH CONG., REPORT ON MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD 17 (Comm. Print 1983); STAFF OF SUBCOMM. ON OVERSIGHT & INVESTIGATIONS, HOUSE COMM. ON ENERGY & COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD & DRUG ADMINISTRATION'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH (Comm. Print 1993); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SENATE COMM. ON GOVERNMENTAL AFFAIRS, GAO/PEMD-87-1, MEDICAL DEVICES - EARLY WARNING OF PROBLEMS IS HAMPERED BY SEVERE UNDERREPORTING 33 (1986); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY AND COMMERCE, GAO/PEMD-88-14, MEDICAL DEVICES - FDA'S 510(K) OPERATIONS COULD BE IMPROVED 18 (1988); D. BRUCE BURLINGTON, FDA CDRH Annual Report Fiscal Year 1998 (visited Mar. 1, 1999) 〈www.fda.gov/ cdrh/annual/fy98rpt.html〉; PRESIDENT WILLIAM CLINTON & VICE PRESIDENT ALBERT GORE, NATIONAL PERFORMANCE REVIEW: REINVENTING DRUG & MEDICAL DEVICE REGULATIONS 18 (1995).
41. See, e.g., STAFF OF HOUSE SUBCOMM. ON OVERSIGHT & INVESTIGATIONS OF THE HOUSE COMM. ON ENERGY & COMMERCE, 98TH CONG., REPORT ON MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD 17 (Comm. Print 1983); STAFF OF SUBCOMM. ON OVERSIGHT & INVESTIGATIONS, HOUSE COMM. ON ENERGY & COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD & DRUG ADMINISTRATION'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH (Comm. Print 1993); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SENATE COMM. ON GOVERNMENTAL AFFAIRS, GAO/PEMD-87-1, MEDICAL DEVICES - EARLY WARNING OF PROBLEMS IS HAMPERED BY SEVERE UNDERREPORTING 33 (1986); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY AND COMMERCE, GAO/PEMD-88-14, MEDICAL DEVICES - FDA'S 510(K) OPERATIONS COULD BE IMPROVED 18 (1988); D. BRUCE BURLINGTON, FDA CDRH Annual Report Fiscal Year 1998 (visited Mar. 1, 1999) 〈www.fda.gov/ cdrh/annual/fy98rpt.html〉; PRESIDENT WILLIAM CLINTON & VICE PRESIDENT ALBERT GORE, NATIONAL PERFORMANCE REVIEW: REINVENTING DRUG & MEDICAL DEVICE REGULATIONS 18 (1995).
42. See, e.g., STAFF OF HOUSE SUBCOMM. ON OVERSIGHT & INVESTIGATIONS OF THE HOUSE COMM. ON ENERGY & COMMERCE, 98TH CONG., REPORT ON MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD 17 (Comm. Print 1983); STAFF OF SUBCOMM. ON OVERSIGHT & INVESTIGATIONS, HOUSE COMM. ON ENERGY & COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD & DRUG ADMINISTRATION'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH (Comm. Print 1993); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SENATE COMM. ON GOVERNMENTAL AFFAIRS, GAO/PEMD-87-1, MEDICAL DEVICES - EARLY WARNING OF PROBLEMS IS HAMPERED BY SEVERE UNDERREPORTING 33 (1986); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY AND COMMERCE, GAO/PEMD-88-14, MEDICAL DEVICES - FDA'S 510(K) OPERATIONS COULD BE IMPROVED 18 (1988); D. BRUCE BURLINGTON, FDA CDRH Annual Report Fiscal Year 1998 (visited Mar. 1, 1999) 〈www.fda.gov/ cdrh/annual/fy98rpt.html〉; PRESIDENT WILLIAM CLINTON & VICE PRESIDENT ALBERT GORE, NATIONAL PERFORMANCE REVIEW: REINVENTING DRUG & MEDICAL DEVICE REGULATIONS 18 (1995).
43. See, e.g., STAFF OF HOUSE SUBCOMM. ON OVERSIGHT & INVESTIGATIONS OF THE HOUSE COMM. ON ENERGY & COMMERCE, 98TH CONG., REPORT ON MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD 17 (Comm. Print 1983); STAFF OF SUBCOMM. ON OVERSIGHT & INVESTIGATIONS, HOUSE COMM. ON ENERGY & COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD & DRUG ADMINISTRATION'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH (Comm. Print 1993); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SENATE COMM. ON GOVERNMENTAL AFFAIRS, GAO/PEMD-87-1, MEDICAL DEVICES - EARLY WARNING OF PROBLEMS IS HAMPERED BY SEVERE UNDERREPORTING 33 (1986); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY AND COMMERCE, GAO/PEMD-88-14, MEDICAL DEVICES - FDA'S 510(K) OPERATIONS COULD BE IMPROVED 18 (1988); D. BRUCE BURLINGTON, FDA CDRH Annual Report Fiscal Year 1998 (visited Mar. 1, 1999) 〈www.fda.gov/ cdrh/annual/fy98rpt.html〉; PRESIDENT WILLIAM CLINTON & VICE PRESIDENT ALBERT GORE, NATIONAL PERFORMANCE REVIEW: REINVENTING DRUG & MEDICAL DEVICE REGULATIONS 18 (1995).
44. See, e.g., STAFF OF HOUSE SUBCOMM. ON OVERSIGHT & INVESTIGATIONS OF THE HOUSE COMM. ON ENERGY & COMMERCE, 98TH CONG., REPORT ON MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD 17 (Comm. Print 1983); STAFF OF SUBCOMM. ON OVERSIGHT & INVESTIGATIONS, HOUSE COMM. ON ENERGY & COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD & DRUG ADMINISTRATION'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH (Comm. Print 1993); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SENATE COMM. ON GOVERNMENTAL AFFAIRS, GAO/PEMD-87-1, MEDICAL DEVICES - EARLY WARNING OF PROBLEMS IS HAMPERED BY SEVERE UNDERREPORTING 33 (1986); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY AND COMMERCE, GAO/PEMD-88-14, MEDICAL DEVICES - FDA'S 510(K) OPERATIONS COULD BE IMPROVED 18 (1988); D. BRUCE BURLINGTON, FDA CDRH Annual Report Fiscal Year 1998 (visited Mar. 1, 1999) 〈www.fda.gov/ cdrh/annual/fy98rpt.html〉; PRESIDENT WILLIAM CLINTON & VICE PRESIDENT ALBERT GORE, NATIONAL PERFORMANCE REVIEW: REINVENTING DRUG & MEDICAL DEVICE REGULATIONS 18 (1995).
45. See, e.g., STAFF OF HOUSE SUBCOMM. ON OVERSIGHT & INVESTIGATIONS OF THE HOUSE COMM. ON ENERGY & COMMERCE, 98TH CONG., REPORT ON MEDICAL DEVICE REGULATION: THE FDA'S NEGLECTED CHILD 17 (Comm. Print 1983); STAFF OF SUBCOMM. ON OVERSIGHT & INVESTIGATIONS, HOUSE COMM. ON ENERGY & COMMERCE, 103D CONG., LESS THAN THE SUM OF ITS PARTS: REFORMS NEEDED IN THE ORGANIZATION, MANAGEMENT, AND RESOURCES OF THE FOOD & DRUG ADMINISTRATION'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH (Comm. Print 1993); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SENATE COMM. ON GOVERNMENTAL AFFAIRS, GAO/PEMD-87-1, MEDICAL DEVICES - EARLY WARNING OF PROBLEMS IS HAMPERED BY SEVERE UNDERREPORTING 33 (1986); GENERAL ACCOUNTING OFFICE, REPORT TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY AND COMMERCE, GAO/PEMD-88-14, MEDICAL DEVICES - FDA'S 510(K) OPERATIONS COULD BE IMPROVED 18 (1988); D. BRUCE BURLINGTON, FDA CDRH Annual Report Fiscal Year 1998 (visited Mar. 1, 1999) 〈www.fda.gov/ cdrh/annual/fy98rpt.html〉; PRESIDENT WILLIAM CLINTON & VICE PRESIDENT ALBERT GORE, NATIONAL PERFORMANCE REVIEW: REINVENTING DRUG & MEDICAL DEVICE REGULATIONS 18 (1995).
46. Revitalizing New Product Development from Clinical Trials Through FDA Review: Hearings on FDA Reform Before the Senate Comm. On Labor and Human Resources, 104th Cong. 209 (1996) (statement of Maurice F. Freeman, Medical Technology Consultants Europe Ltd.) [hereinafter Revitalizing Hearings].
47. Revitalizing New Product Development from Clinical Trials Through FDA Review: Hearings on FDA Reform Before the Senate Comm. On Labor and Human Resources, 104th Cong. 209 (1996) (statement of Maurice F. Freeman, Medical Technology Consultants Europe Ltd.) [hereinafter Revitalizing Hearings].
48. See The Wilkerson Group, Inc., Forces Reshaping the Performance and Contribution of the U.S. Medical Device Industry (1995) (unpublished manuscript, on file with the Health Industry Manufacturers Association).
49. U.S. GENERAL ACCOUNTING OFFICE, REPORT TO THE SENATE COMM. ON LABOR & HUMAN RESOURCES, MEDICAL DEVICE REGULATION - TOO EARLY TO ASSESS EUROPEAN SYSTEM'S VALUEAS MODEL FOR FDA, GAO/HEHS-96-652 (1996) [hereinafter GAO/HEHS-96-65].
50. Id.
51. Revitalizing Hearings, supra note 39, at 209.
52. Id.
53. Id.
54. See generally GAO/HEHS-96-65, supra note 41, at 11, 32. The independent reviewer performs a type-examination to test representative samples of a device to determine if it meets certain standards.
55. Council Directive 93/42/EEC, art. 16, 1993 O.J. (L 169); Council Directive 98/79/EC, art. 15, 1998 O.J. (L 331); Council Directive 90/385/EEC, art. 11, 1990 O.J. (L 189). NBs are entities that Member States have notified the Commission and other Member States as possessing the technical ability to assess manufacturers' quality systems and/or review medical devices for certification.
56. Revitalizing Hearings, supra note 39, at 210.
57. Id.
58. See generally Theresa J. Pulley Radwan, Meeting the Objectives of the MDA: Implied Preemption of State Tort Claims by the Medical Device Amendments, 10 J.L. & HEALTH 343, 349 (1996); Harvard Law Review Association, FDA Reform and the European Medicines Evaluation Agency, 108 HARV. L. REV. 2009, 2016 (1995).
59. See generally Theresa J. Pulley Radwan, Meeting the Objectives of the MDA: Implied Preemption of State Tort Claims by the Medical Device Amendments, 10 J.L. & HEALTH 343, 349 (1996); Harvard Law Review Association, FDA Reform and the European Medicines Evaluation Agency, 108 HARV. L. REV. 2009, 2016 (1995).
60. FDAMA of 1997, Pub. L. No. 105-115, 111 Stat. at 2369 (codified as amended at 21 U.S.C. § 393).
61. Id.
62. Id.
63. Council Directive 90/385/EEC, 1990 O.J. (L 189) 1; Council Directive 93/42/EEC, 1993 O.J. (L 169) 1; Council Directive 98/79/EC, 1998 O.J. (L 331) 1; see also KATHLEEN HASTINGS, FOOD & DRUG ADMIN., OFFICE OF POLICY/INTERNATIONAL POLICY, REGULATING MEDICAL DEVICES: A COMPARISON OF U.S. AND FOREIGN SYSTEMS AND ADVANTAGE OF THE U.S. SYSTEM OVER OTHERS 8 (1996).
64. Letter from Linda R. Horton, Director, International Policy, Food & Drug Administration, to author (Feb. 24, 1999).
65. See, e.g., Medical Devices; Current Good Manufacturing Practices (CGMP) Final Rule; Quality System Regulation, Part VII. 61 Fed. Reg. 52,602 (Oct. 7, 1996) (codified at 21 C.F.R. parts 808, 812, 820); Agreement on Mutual Recognition Between the United States of America and the European Community (visited Jan. 30, 1999) 〈www.europa.eu.int〉 [hereinafter US/EU MRA].
66. OFFICE OF POLICY, FOOD & DRUG ADMIN., A STATUS REPORT ON INTERNATIONAL HARMONIZATION OF REGULATORY REQUIREMENTS AND STANDARDS 1 (1998).
67. 61 Fed. Reg. at 14,789; 63 Fed. Reg. at 58,746.
68. 21 U.S.C. § 360.
69. 63 Fed. Reg. at 58,746.
70. See generally CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., AN INTRODUCTION TO MEDICAL DEVICE REGULATION 1 (HHS Publication 92-4222, 1992); CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., REGULATION OF MEDICAL DEVICES: BACKGROUND INFORMATION FOR INTERNATIONAL OFFICIALS 1 (1999).
71. See generally CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., AN INTRODUCTION TO MEDICAL DEVICE REGULATION 1 (HHS Publication 92-4222, 1992); CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., REGULATION OF MEDICAL DEVICES: BACKGROUND INFORMATION FOR INTERNATIONAL OFFICIALS 1 (1999).
72. See generally Delegation of the European Commission to the United States, European Union, The European Commission 1995-2000 (last modified Dec. 22, 1998) 〈www.europa.eu.int/abc-en.htm〉.
73. Directorate General III, The European Commission, Who's Who in DG III? (last modified Dec. 22, 1998) 〈www.europa.eu.int/comm/dg03/organ_en.htm〉.
74. Linda R. Horton, Medical Device Regulation in the European Union, 50 FOOD & DRUG L.J. 467 (1995) (stating that the competent authority of a Member State is usually its Health Ministry).
75. Council Directive 98/79/EC, 1998 O.J. (L 331) 1.
76. Id.
77. Id. art. 9.
78. Id. art. 15.6.
79. Id.
80. Id.
81. 61 Fed. Reg. at 14,789, 14,794.
82. Id.
83. Id. at 14,795.
84. Id. at 14,794.
85. 21 U.S.C. § 360(m).
86. Council Directive 98/79/EC, Annex IX, 1998 O.J. (L 331).
87. Id.
88. Id.
89. GAO/HEHS-96-65, supra note 41, at 15.
90. 61 Fed. Reg. at 14,794.
91. GAO/HEHS-96-65, supra note 41, at 15.
92. US/EU MRA, supra note 56; LINDA R. HORTON, MICHELLE HOYTE & NAOMI KAWIN, FUNDAMENTALS OF LAW AND REGULATION - INTERNATIONAL HARMONIZATION OF MEDICAL DEVICE REGULATION 555,601 (FDLI 1997) [hereinafter HORTON, HOYTE & KAWIN].
93. US/EU MRA, supra note 56; LINDA R. HORTON, MICHELLE HOYTE & NAOMI KAWIN, FUNDAMENTALS OF LAW AND REGULATION - INTERNATIONAL HARMONIZATION OF MEDICAL DEVICE REGULATION 555,601 (FDLI 1997) [hereinafter HORTON, HOYTE & KAWIN].
94. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES, GUIDANCE FOR STAFF, INDUSTRY, AND THIRD PARTIES: THIRD PARTY PROGRAMS UNDER THE SECTORAL ANNEX ON MEDICAL DEVICES TO THE AGREEMENT ON MUTUAL RECOGNITION BETWEEN THE UNITED STATES OF AMERICA & THE EUROPEAN COMMUNITY (MRA) - GUIDANCE, 1 (1999).
95. See generally GAO/HEHS-96-65, supra note 41, at 7; HASTINGS, supra note 54, at 8.
96. See, e.g., CLINTON, supra note 38, at 27.
97. Council Directive 93/42/EEC, Annex L1, 1993 O.J. (L 169); Council Directive 98/79/EC, 1998 O.J. (Annex I.A.1) (L 331); see also Council Directive 90/385/EEC, Annex 1.1,5, 1990 O.J. (L 189); see generally Harvard Law Review Association, supra note 50, at 2025 (Cultural differences may contribute to a difference in regulatory schemes. The comment suggests that cultural attitude toward risk accounts for societal values placed on regulatory mechanisms. An example illustrates that Americans view risks differently from other cultures. A previous study revealed that British scientists and government policy makers recognized risk only when there existed "persuasive evidence of actual harm." In the U.S., risk must be acknowledged even if there was no direct proof of harm to the public. Equally important in shaping a regulatory scheme is the cultural attitude toward morality. The comment uses the European abortion drug RU-486 as an example to illustrate the differences in attitude that European and U.S. regulatory agencies had toward the drug's approval.).
98. CLINTON, supra note 38, at 27.
99. 21 U.S.C. § 360(c).
100. GAO/HEHS-96-65, supra note 41, at 8.
101. CLINTON, supra note 38, at 27.
102. Council Directive 98/79/EC, Annex I.A.3-5, 1998 O.J.(L 331).
103. Id.
104. GAO/HEHS-96-65, supra note 41, at 8.
105. Id.
106. See generally GAO/HEHS-96-65, supra note 41, at 13.
107. 63 Fed. Reg. at 63,222. FDAMA created an exemption from premarket notification for Class I devices except those "reserve devices" intended for "a use which is of substantial importance in preventing impairment of human health," or that present "a potential unreasonable risk of illness or injury." A proposed rule on the exemption of Class I devices from 510(k) premarket notification was announced November 1998.
108. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., Medical Device Regulatory Program Re-engineering (last modified Mar. 19, 1997) 〈www.fda.gov/cdrh/rengmdrp.html〉 Reengineering Accomplishments, supra note 25.
109. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., Medical Device Regulatory Program Re-engineering (last modified Mar. 19, 1997) 〈www.fda.gov/cdrh/rengmdrp.html〉 Reengineering Accomplishments, supra note 25.
110. Id.
111. Id.
112. CENTER FOR DEVICES & RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., New Model Medical Device Development Process - Guidance for Industry (last modified July 21, 1998) 〈www.fda.gov/cdrh/pmal/ newmod.html〉.
113. Id.
114. 61 Fed. Reg. at 52,602.
115. EN 46000 applies to all medical devices in the EU. The EN 46000 standard was adopted from the International Standards Organization ISO-9000 series of Quality System standards that have worldwide industrial acceptance. Horton, supra note 64, at 472.
116. Council Directive 98/79/EC, art. 9, 1998 O.J. (L 331).
117. Id.
118. Id.
119. Id. Annex IV.4.
120. Id.
121. See generally Study Group 2, Global Harmonization Task Force, Comparison of the Device Adverse Report Systems in USA, Europe, Canada, Australia, and Japan (last modified June 29, 1999) 〈www.ghtf.org/ sg2/inventorysg2/sg2-n6r2.pdf〉 [hereinafter Device Adverse Report Systems].
122. See generally Study Group 2, Global Harmonization Task Force, Comparison of the Device Adverse Report Systems in USA, Europe, Canada, Australia, and Japan (last modified June 29, 1999) 〈www.ghtf.org/ sg2/inventorysg2/sg2-n6r2.pdf〉 [hereinafter Device Adverse Report Systems].
123. 21 U.S.C. § 360(i).
124. Council Directive 98/79/EC, Annex III.5, IV.3.1, VI.3VII.1, 1998 O.J. (L 331).
125. Id.
126. Id. art. 10.1.
127. Id.
128. 21 U.S.C. § 360(i).
129. Id.
130. 58 Fed. Reg. 11,768 (Feb. 26, 1993); see also GENERAL ACCOUNTING OFFICE, REPORT TO CONGRESSIONAL COMMITTEES, GAO/HEHS-97-21, MEDICAL DEVICE REPORTING - IMPROVEMENTS NEEDED IN FDA's SYSTEM FOR MONITORING PROBLEMS WITH APPROVED DEVICES 9 (1997).
131. Council Directive 93/42/EEC, art. 10.2, 1993 O.J. (L 169); Council Directive 98/79/EC, art. 11.2, 1998 O.J. (L 331).
132. GENERAL ACCOUNTING OFFICE, STATEMENT OF CHARLES A. BOWSHER, COMPTROLLER GENERAL TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY & COMMERCE, GAO/T-PEMD-90-2, MEDICAL DEVICES - THE PUBLIC HEALTH AT RISK 42 (1989); Device Adverse Report Systems, supra note 109.
133. GENERAL ACCOUNTING OFFICE, STATEMENT OF CHARLES A. BOWSHER, COMPTROLLER GENERAL TO THE CHAIRMAN, SUBCOMM. ON HEALTH & THE ENVIRONMENT, HOUSE COMM. ON ENERGY & COMMERCE, GAO/T-PEMD-90-2, MEDICAL DEVICES - THE PUBLIC HEALTH AT RISK 42 (1989); Device Adverse Report Systems, supra note 109.
134. Id.
135. 21 U.S.C. § 360(g).
136. Council Directive 90/385/EEC, art. 7, 1990 O.J. (L 189); Council Directive 93/42/EEC, art. 8, 14, 1993 O.J. (L 169) amended by Council Directive 98/79/EC, art. 21.2(d), 1998 O.J. (L 331); Council Directive 98/79/EC, art. 8, 13, 1998 O.J. (L 331).
137. Council Directive 98/79/EC, art. 15.6, 1998 O.J. (L 331), Council Directive 93/42/EEC, art. 14, 1993 OJ, (L 169), amended by Council Directive 98/79/EC, art. 21.2(d), 1998 O.J. (L 331).
138. 21 U.S.C. § 360(1).
139. Id. § 360(k).
140. Id. § 360(i).
141. Council Directive 98/79/EC, art. 11, 1998 O.J. (L 331).
142. Id.
143. The United States may adopt laws that conform to the medical device provisions of the FDCA; see, e.g., FDCA § 521, 21 U.S.C. § 360(k). FDA also may commission state officials to enforce federal requirements under FDCA; see, e.g., FDCA § 703, 21 U.S.C. § 373; Delegations from the Secretary, the Assistant Secretary for Health, and Public Health Service Officiais, 21 C.F.R. pt. 5.10.
144. HASTINGS, supra note 54, at 23.
145. Id, at 17.
146. Id.
147. 63 Fed. Reg. at 46,227.
148. Global Harmonization Task Force - Study Group 2: Medical Device Vigilance/Post-Market Surveillance, Food and Drug Administration, Fifth and Final Draft of the Charge for SG2: 31 May 1996 (last modified May, 1999) 〈www.ghtf.org/sg2/inventorysg2/sg2-n16r5.pdf〉 [hereinafter SG2].
149. Global Harmonization Task Force - Study Group 2: Medical Device Vigilance/Post-Market Surveillance, Food and Drug Administration, Fifth and Final Draft of the Charge for SG2: 31 May 1996 (last modified May, 1999) 〈www.ghtf.org/sg2/inventorysg2/sg2-n16r5.pdf〉 [hereinafter SG2].
150. Council Directive 98/79/EC, 1998 O.J. (L 331) 1.
151. Id. art 22.
152. Council Directive 90/385/EEC, art. 16, 1990 O.J. (L 189).
153. Horton, supra note 64, at 474.
154. Id.
155. Id.
156. Case 239/95, Commission v. Kingdom of Belgium, 1996 E.C.R. 1459.
157. Id.
158. Id.
159. Council Directive 93/42/EEC, art 22, 1993 O.J. (L 169).
160. Case 294/96, Commission v. Kingdom of Belgium, 1997 E.C.R. 1781.
161. Id.
162. Written Question 391/88 by Leoluca Orlando to the Commission. Failure of the Italian Authorities to Incorporate Directive 93/42/EEC, 1998 O.J. (C304) 9.
163. Id.
164. Id.
165. Id.
166. Council Directive 98/79/EC, art 22, 1998 O.J. (L 331) 15.
167. Horton, supra note 55 (Possible exceptions are France and Germany that have, for many years, maintained approval systems for IUDs akin to pharmaceutical approval systems. France, in particular, had raised concerns about the better use of NBs for IVDs during consideration of the EU Directive).
168. 21 U.S.C. § 393.
169. Revitalizing Hearings, supra note 39 at 209 (statement of Maurice F. Freeman, Medical Technology Consultants Europe Ltd.).
170. GAO/HEHS-96-65, supra note 41, at 18.
171. Id.
172. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD & DRUG ADMIN., FDA CDRH ANNUAL REPORT FISCAL YEAR 1999 [hereinafter REPORT 1999] 〈www.fda.gov/cdrh/annual/fy99rpt.pdf〉.
173. Id. at 1; BURLINGTON 1998, supra note 38, at 1.
174. Id.
175. Gordon R. Higson, Medical Device Approval Times in Europe, THE COMPLETE EUROPEAN TRADE DIGEST 2 (Fall 1996).
176. Id. at 4. Metrological devices measure functions.
177. Id.
178. Id.; Horton, supra note 55 (commenting that there are reports that NBs are becoming more stringent in their reviews, as more parts of the EU regulation programs are put in place, more device standards are issued, and auditors acquire experience).
179. See generally, GAO/HEHS - 96-65, supra note 41, at 7; HASTINGS, supra note 54, at 8.
180. See HORTON, HOYTE & KAWIN, supra note 82, at 599.
181. See, e.g., Global Harmonization Task Force, General Information (visited Feb. 10, 2000) 〈www.ghtf.org〉. EU and these nations are members of the Global Harmonization Task Force, an organization instrumental in promoting internal harmonization of regulatory controls.
182. HORTON, HOYTE & KAWIN, supra note 82, at 582.
183. Id.
184. Pub. L. No. 101-629, § 15, 104 Stat. at 4525 (codified as amended at 21 U.S.C. § 360).
185. Pub. L. No. 105-115, § 410, 111 Stat. at 2372 (codified as amended at 21 U.S.C. § 360 j(f)(1)(B)).
186. 56 Fed. Reg. 15,626 (Apr. 17, 1991); 55 Fed. Reg. 24,544 (June 15, 1990); 55 Fed. Reg. 49,644 (Nov. 30, 1990); 58 Fed. Reg. 61,952 (Nov. 23, 1993); 60 Fed. Reg. 37,856 (July 24, 1995); 60 Fed. Reg. 37,856 (Aug. 23, 1995); 60 Fed. Reg. 44,036 (Aug. 24, 1995).
187. 61 Fed. Reg. at 52,602 (codified at 21 C.F.R. pts. 808, 812, 820).
188. Id. at 52,605.
189. US/EU MRA, supra note 56.
190. Id.
191. Directorate General I, The European Commission, Conclusion of Agreements Between the European Community and Australia, and the European Community and New Zealand on Mutual Recognition in Relation to Conformity Assessment 1 (1998) (visited Jan. 1, 1999) 〈www.europa.eu.int/comm/dg01/0510mra.htm〉.
192. US/EU MRA, supra note 56, at Sectoral Annex on Medical Devices -ch, 1 art.2.1.
193. 63 Fed. Reg. at 17, 744.
194. Id. at 60,121 (to be codified at 21 C.F.R. pt. 26).
195. Id. at 60,139 (to be codified at 21 C.F.R. pt. 26).
196. 63 Fed. Reg. at 6O, 161 (to be codified at 21 C.F.R. pt. 26.61); US/EU MRA, supra note 56, art 2.
197. Id.
198. 63 Fed. Reg. at 60,146 (to be codified at 21 C.F.R. pt. 26.33).
199. Id.
200. Id.
201. Id. at 60,146 (to be codified at 21 C.F.R. pt. 26.39).
202. Id.
203. Id. at 60,148.
204. Id. at 60,147.
205. See HORTON, HOYTE & KAWIN, supra note 82, at 585.
206. 60 Fed. Reg. at 31,485.
207. Id.
208. Id.
209. Id. at 31, 486.
210. Id.
211. See HORTON, HOYTE & KAWIN, supra note 82, at 587; Global Harmonization Task Force Homepage (visited Mar. 1, 1999) 〈www.ghtf.org〉.
212. Id.
213. Id.
214. Id.
215. Id.
216. Global Harmonization Task Force, History of GHTF (visited Feb. 10, 2000) 〈www.ghtf.org〉.
217. 63 Fed. Reg. at 57,697.
218. Study Group 1, Global Harmonization Task Force, Essential Principles of Safety and Performance of Medical Devices - Final Working Draft 1 (1998) (visited Jan. 1, 1999) 〈www.fda.gov/ohrms/dockets/98fr/ 980878gd.pdf〉.
219. 63 Fed. Reg. at 57,697.
220. SG2, supra note 134, at 1.
221. 63 Fed. Reg. at 46,227.
222. SG2, supra note 134, at 1.
223. Device Adverse Report Systems, supra note 109, at 1.
224. Study Group 2, Global Harmonization Task Force, Adverse Event Reporting Guideline for the Medical Device Manufacturer or its Authorized Representative, GHTF-FD: 99-7 1 (1999) (last modified May, 1999) 〈www.ghtf.org/sg2/inventorysg2/sg2-n21r8.pdf〉.
225. Study Group 2, Global Harmonization Task Force, Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices, GHTF-FD: 99-7 1 (1999) (visited Feb. 24,2000) 〈www.ghtf.org/sg2/inventorysg2/sg2-n8r4.pdf〉.
226. Study Group 2, Global Harmonization Task Force, Global Medical Devices Vigilance Report, GHTF-FD: 99-5 1 (1999) (last modified June 29, 1999) 〈www.ghtf.org/sg2/inventorysg2/sg2-n9r5.pdf〉.
227. Global Harmonization Task Force, Study Group 2, Minimum Data Set for Manufacturer Reports to Competent Authority, GHTF-FD: 99-3 1 (1999) (visited Feb. 10, 2000) 〈www.ghtf.orgs/sg2/inventorysg2/ sg2-n7r1.pdf〉.
228. See HORTON, HOYTE & KAWIN, supra note 82, at 587.
229. 63 Fed. Reg. at 38,411.
230. Study Group 3, Global Harmonization Task Force, Draft Process Validation Guidance for Medical Device Manufacturers, SG3-N99010 1 (1999) (visited Feb. 24, 2000) 〈www.ghtf.org/sg3/inventorysg3/ processval.pdf〉.
231. Study Group 3, Global Harmonization Task Force, Guidance on Quality Systems for the Design & Manufacturing of Medical Devices, SG3-N99-8 1 (1999) (visited Feb. 24, 2000) 〈www.ghtf.org/sg3/ inventorysg3/gqualitysys.pdf〉; Study Group 3, Global Harmonization Task Force, Design Control Guidance for Medical Device Manufacturers, SG3-N99-9 1 (1999) (visited Feb. 24, 2000) 〈www.ghtf.org/sg3/ inventorysg3/descontrolguid.pdt〉.
232. Study Group 3, Global Harmonization Task Force, Guidance on Quality Systems for the Design & Manufacturing of Medical Devices, SG3-N99-8 1 (1999) (visited Feb. 24, 2000) 〈www.ghtf.org/sg3/ inventorysg3/gqualitysys.pdf〉; Study Group 3, Global Harmonization Task Force, Design Control Guidance for Medical Device Manufacturers, SG3-N99-9 1 (1999) (visited Feb. 24, 2000) 〈www.ghtf.org/sg3/ inventorysg3/descontrolguid.pdt〉.
233. See HORTON, HOYTE & KAWIN, supra note 82, at 589.
234. It can be argued that the harmonized postmarket vigilance and adverse incident reporting system may show only the differences between the two systems in the number of reports submitted, and among the reports, the number of those that each authority has interpreted to meet the agreed criteria.
235. See generally HORTON, HOYTE & KAWIN, supra note 82, at 600-02.