Regulation of medical devices in the United States and European Union

New England Journal of Medicine

Volumn 366, Issue 9, 2012, Pages 848-855

  Kramer, Daniel B ^a,b   Xu, Shuai ^a   Kesselheim, Aaron S ^a,c  

^a HARVARD MEDICAL SCHOOL   (United States)

^b BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CATHETER ABLATION; CLINICAL EVALUATION; CONFLICT OF INTEREST; DEFIBRILLATOR; DEVICE SAFETY; EUROPEAN UNION; HEALTH CARE ACCESS; HEART ATRIUM FIBRILLATION; HUMAN; HUMAN RIGHTS; LAW; LENS IMPLANT; MEDICAL DEVICE; MEDICAL ETHICS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH; QUALITY OF LIFE; REVIEW; UNITED STATES;

EID: 84857885489     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMhle1113918     Document Type: Article

References (73)

1. Committee Staff, House of Representatives Committee on Energy and Commerce. Internal memorandum, October 14, 2011 (http://energycommerce.house. gov/media/file/PDFs/101411tenwaysmemo.pdf).
2. PricewaterhouseCoopers. Medical technology innovation scorecard: the race for global leadership. January 2011 (http://pwchealth.com/cgi-local/hregister. cgi?link=reg/innovation-scorecard.pdf).
3. Wizemann T, ed. Public health effectiveness of the FDA 510(k) clearance process: balancing patient safety and innovation: workshop report. Washington, DC: National Academies Press, 2010.
4. Hines JZ, Lurie P, Yu E, Wolfe S. Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med 2010;7(7):e1000280.
5. Sweet BV, Schwemm AK, Parsons DM. Review of the processes for FDA oversight of drugs, medical devices, and combination products. J Manag Care Pharm 2011;17:40-50.
6. Chai JY. Medical device regulation in the United States and the European Union: a comparative study. Food Drug Law J 2000;55:57-80. (Pubitemid 30214817)
7. Gottlieb S. How the FDA could cost you your life. Wall Street Journal. October 3, 2011:A17.
8. Ferman J. Medical devices industry assessment: report of the Office of Health and Consumer Goods Health Team International Trade Administration, July 12, 2010 (http://www.trade.gov/td/health/ Medical%20Device%20Industry%20Assessment%20FINAL%20II%203-24-10.pdf).
9. Thompson M, Heneghan C, Billingsley M, Cohen D. Medical device recalls and transparency in the UK. BMJ 2011;342:d2973.
10. Horton R. A serious regulatory failure, with urgent implications. Lancet 2012;379:1060.
11. O'Dowd A. UK launches inquiry into safety of PIP breast implants. BMJ 2012;344:e11.
12. Gallagher J. PIP breast implants: European Commission says reform needed. BBC News. January 14, 2012.
13. Medical Device Amendments. Pub. L. No. 94-295, 90 Stat. 539 (1976).
14. Medical Device User Fee and Modernization Act, Pub. L. No. 107-250, 116 Stat. 1588 (2002).
15. Maisel WH. Medical device regulation: an introduction for the practicing physician. Ann Intern Med 2004;140:296-302. (Pubitemid 38200536)
16. Medical devices: device classification. Silver Spring, MD: Food and Drug Administration, April 27, 2009 (http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/Overview/ ClassifyYourDevice/default.htm).
17. Sapirstein W, Alpert S, Callahan TJ. The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices. Circulation 1994;89:1900-2. (Pubitemid 24114269)
18. FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process. Washington, DC: Government Accountability Office, January 2009 (http://www.gao.gov/assets/290/284882.pdf).
19. 21 Code of Federal Regulations 814.82(a)(2) (2011).
20. Medical devices; humanitarian use of devices - FDA: final rule. Fed Regist 1998;63:59217-22.
21. Safe Medical Devices Act. Pub L No. 101-629, 104 Stat 4511 (1990).
22. Brown SL, Bright RA, Tavris DR. Medical device epidemiology and surveillance: patient safety is the bottom line. Expert Rev Med Devices 2004;1:1-2. (Pubitemid 40220412)
23. Fraser AG, Daubert JC, Van de Werf F, et al. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Eur Heart J 2011;32:1673-86.
24. European Council. Directive 93/42/EEC concerning medical devices. June 14, 1993 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG: 1993L0042:20071011:en:PDF).
25. European Commission. Classification of medical devices (MEDDEV 2.4/1 Rev. 9). June 2010 (http://ec.europa.eu/consumers/sectors/medical-devices/files/ meddev/2-4-1-rev-9-classification-en.pdf).
26. Idem. Classification criteria (Annex IX of Directive 93/42/EEC). June 2010 (http://www.lne-gmed.com/pdf/en/annex9-directive-93-42-amended.pdf).
27. Idem. Commission communication in the framework of the implementation of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. 2011 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2011:016:0001:0007: EN:PDF).
28. European Parliament and Council. Directive 98/79/EC, Annex IA. October 27, 1998 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1998:331: 0001:0037:EN:PDF).
29. European Commission. Clinical evaluation: a guide for manufacturers and notified bodies (MEDDEV 2.7.1 Rev.3). December 2009 (http://ec.europa.eu/ consumers/sectors/medical-devices/files/meddev/2-7-1rev-3-en.pdf).
30. Global Harmonization Task Force. Review of current requirements on postmarket surveillance. May 2005 (http://www.ghtf.org/documents/sg2/sg2-n47r4. pdf).
31. European Commission. Guidelines on post market clinical follow-up (MEDDEV 2.12-2). May 2004 (http://ec.europa.eu/health/medical-devices/files/meddev/2- 12-2-05-2004-en.pdf).
32. Hamburg MA, Sharfstein JM. The FDA as a public health agency. N Engl J Med 2009;360:2493-5.
33. Sharfstein JM. The FDA - a misunderstood agency. JAMA 2011;306:1250-1.
34. O'Riordan M. Benefit of AF catheter-ablation system does not outweigh risks, say FDA advisors. Theheart.org. October 27, 2011 (http://dev.theheart. org/article/1301231.do).
35. Council of the European Communities. Council Directive 93/42/EEC. June 14, 1993 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG: 1993L0042:20071011:EN:PDF).
36. Council of the European Union. Council Directive 2007/47/ EC. September 21, 2007 (http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247: 0021:0055:EN:PDF).
37. Kaplan AV, Baim DS, Smith JJ, et al. Medical device development: from prototype to regulatory approval. Circulation 2004; 109:3068-72.
38. Webb JG, Carere RG, Virmani R, et al. Retrieval and analysis of particulate debris after saphenous vein graft intervention. J Am Coll Cardiol 1999;34:468-75.
39. Baim DS, Wahr D, George B, et al. Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorto-coronary bypass grafts. Circulation 2002;105:1285-90. (Pubitemid 34260417)
40. Grunkemeier GL, Jin R, Starr A. Prosthetic heart valves: objective performance criteria versus randomized clinical trial. Ann Thorac Surg 2006;82:776-80.
41. Food and Drug Administration. CardioSEAL Septal Occlusion System with Qwik Load: summary of safety and effectiveness data (http://www.accessdata.fda. gov/cdrh-docs/pdf/P000049b.pdf).
42. Idem. Amplatzer Patent Ductus Arteriorosus Occlusion Device: summary of safety and effectiveness data (http://www.accessdata.fda.gov/cdrh-docs/pdf2/ P020024b.pdf).
43. Wilber DJ, Pappone C, Neuzil P, et al. Comparison of antiarrhythmic drug therapy and radiofrequency catheter ablation in patients with paroxysmal atrial fibrillation: a randomized controlled trial. JAMA 2010;303:333-40.
44. Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2007;4: 892-6. (Pubitemid 46959208)
45. DiBardino DJ, Mayer JE Jr. Continued controversy regarding adverse events after Amplatzer septal device closure: mass hysteria or tip of the iceberg? J Thorac Cardiovasc Surg 2011;142:222-3.
46. Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther 2010;17:2-7.
47. Altenstetter C. EU and member state medical devices regulation. Int J Technol Assess Health Care 2003;19:228-48. (Pubitemid 36356342)
48. Hulstaert F, Neyt M, Vinck I, et al. The pre-market clinical evaluation of innovative high-risk medical devices. Brussels: Belgian Health Care Knowledge Centre (KCE), 2011. (http://kce.fgov.be/sites/default/files/page-documents/kce- 158c -innovative-high-risk-medical-devices-0.pdf).
49. Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet 2009;374:534-42. [Erratum, Lancet 2009;374:1596.]
50. Cingolani E, Stevens S, Shehata M, Diamond GA, Kaul S. Medical device regulatory reform: insights from the Watchman left atrial appendage closure technology for stroke prophylaxis in atrial fibrillation. Arch Intern Med 2011;171:1670-2.
51. Maisel WH. Left atrial appendage occlusion - closure or just the beginning? N Engl J Med 2009;360:2601-3.
52. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-85. [Erratum, JAMA 2010;303:422.]
53. Idem. Gender bias in studies for Food and Drug Administration premarket approval of cardiovascular devices. Circ Cardiovasc Qual Outcomes 2011;4:165-71.
54. Chen CE, Dhruva SS, Bero LA, Redberg RF. Inclusion of training patients in US Food and Drug Administration premarket approval cardiovascular device studies. Arch Intern Med 2011;171:534-9.
55. Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med 2011;171:1006-11.
56. Food and Drug Administration. 515 program initiative. November 17, 2011 (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDRH/ CDRHTransparency/ucm240310.htm).
57. Heneghan C, Thompson M, Billingsley M, et al. Medicaldevice recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 2011;1(1):e000155.
58. Laskey WK, Yancy CW, Maisel WH. Thrombosis in coronary drug-eluting stents: report from the meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health, December 7-8, 2006. Circulation 2007;115:2352-7. (Pubitemid 46685904)
59. Laskey WK. Cardiovascular device development: drug-eluting stents and implantable devices for the treatment of heart failure - the view from the Circulatory System Advisory Panel. Am J Ther 2005;12:179-82. (Pubitemid 40516036)
60. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006;295:1901-6.
61. European Commission. Medical devices: guidance MEDDEVs. June 10, 2011 (http://ec.europa.eu/health/medical-devices/documents/guidelines/index-en.htm).
62. Food and Drug Administration. Medical Device User Fee Program Public Meeting, September 14, 2010 (http://www.fda.gov/downloads/MedicalDevices/ NewsEvents/Workshops Conferences/UCM229385.pdf).
63. Okie S. Reviving the FDA. N Engl J Med 2010;363:1492-4.
64. Wood AJ. Playing "kick the FDA" - risk-free to players but hazardous to public health. N Engl J Med 2008;358:1774-5. (Pubitemid 351581188)
65. CE marking: the fast route to compliance in the European Union. Hertfordshire, United Kingdom, BSI (http://www.bsigroup.com/upload/ Product%20Services/About%20CE%20marking/CE-Brochure-2010.pdf).
66. Shuren J. Statement before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, US House of Representatives (http://democrats.energycommerce.house.gov/sites/default/files/image-uploads/ Testimony-07.20.11-Shuren.pdf).
67. Gollaher DL, Goodall S. Competitiveness and regulation: the FDA and the future of America's biomedical industry. February 2011 (http://www.bcg.com/ documents/file72060.pdf).
68. Bates ER. Treatment options in severe aortic stenosis. Circulation 2011;124:355-9.
69. Leon MB, Smith CR, Mack M, et al. Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607.
70. Reynolds MR, Magnuson EA, Lei Y, et al. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis. Circulation 2011;124:1964-72.
71. DePonte SL. Covidien: urgent medical device recall, PleuraSeal Lung Sealant System. October 8, 2010 (http://www.covidien.com/recall/pages.aspx).
72. Schreyögg J, Bäumler M, Busse R. Balancing adoption and affordability of medical devices in Europe. Health Policy 2009;92:218-24. [Erratum, Health Policy 2010;94:90.]
73. Makower J, Meer A, Denend L. FDA impact on U.S. medical technology innovation: a survey of over 200 medical technology companies. November 18, 2010 (http://www.nvca.org/index.php?option=com-docman&tak-doc-download&gid= 669&Itemid-93).