Skip to main content Accessibility help
×
Home
Hostname: page-component-564cf476b6-s5ssh Total loading time: 0.285 Render date: 2021-06-18T19:38:25.021Z Has data issue: true Feature Flags: { "shouldUseShareProductTool": true, "shouldUseHypothesis": true, "isUnsiloEnabled": true, "metricsAbstractViews": false, "figures": true, "newCiteModal": false, "newCitedByModal": true, "newEcommerce": true }

US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States

Published online by Cambridge University Press:  20 January 2017

Christa Altenstetter
Affiliation:
The City University of New York’s (CUNY) Graduate Center and Queens College

Abstract

The literature on the regulation of drugs at the FDA and the European Union is substantial, yet little research has provided comparative analyses and robust empirical data on the regulation of medical devices in the United States and the European Union. As medical and health markets become increasingly globalized, and the U.S. and the EU compete for leadership and recognition, salient domestic regulatory issues are becoming increasingly international and transnational policy issues. Building on Carpenter's (2010) work on drug regulation at the FDA, but taking a slightly narrower yet at the same time a broader approach by drawing on interdisciplinary studies instead of limiting ourselves to only the Political Science literature, this comparison focuses on key aspects of risk regulation and governance of medical devices in the U.S. and the EU, and shows how and why individual and organizational learning is imperative in each case.

Type
Symposium on the EU's New Medical Devices Regulatory Framework
Copyright
Copyright © Cambridge University Press 2013

Access options

Get access to the full version of this content by using one of the access options below.

References

1 Carpenter, Daniel, Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA (Princeton, NJ: Princeton University Press 2010)Google Scholar.

2 Hodges, Christopher, European Regulation of Consumer Product Safety (Oxford: Oxford University Press 2005)CrossRefGoogle Scholar; Nottage, Luke, “Comparing Product Safety and Liability Law in Minamata to Mad Cows – and Mitsubishi”, in Fairgrieve, Duncan (ed.), Product Liability Law in Comparative Perspective (Cambridge: Cambridge University Press 2005), pp. 334 et sqq CrossRefGoogle Scholar.

3 Institute of Medicine, Medical Devices and the Public's Health. The FDA 510(k) Clearance Process at 35 Years (Washington, DC: The National Academies Press 2011a), at pp. 183184 Google Scholar.

4 Wilson, Graham K., Business and Politics. A Comparative Introduction, 3rd ed. (Chatham, NJ: Chatham House Publishers, Inc. 2002)Google Scholar.

5 BCG Boston Consulting Group, “EU Medical Device Approval Safety Assessment. A Comparative Analysis of Medical Devices Recalls 2005–2009”,January 2011, available on the Internet at: <www.medtecheurope.org.newsletternews/203/89> (last accessed on 29 April 2013); BCG Boston Consulting Group, “Regulation and Access to Innovative Medical Technologies. A comparison of the FDA and EU Approval Processes and their Impact on Patients and Industry”, June 2012, available on the Internet at: <www.medtecheurope.org.newsletternews/203/89> (last accessed on 29 April 2013).

6 Richard Deyo, “Don't Be Eager to Try the Latest Medical Gadgets”, The Seattle Times, 5 June 2008, available on the Internet at: <seattletimes.newsource.com> (last accessed on 6 August 2008).

7 Boston Consulting Group, supra note 5.

8 The main congressional research materials used are as follows: The US Senate Health, Education, Labor and Pension Committee, The US Senate Finance Committee, The Senate Special Committee on Aging, The House Energy and Commerce Committee – Subcommittee on Health, and the House Ways and Means Committee in the period of 1994 to 2012.

9 European Parliament documents available on the internet at: <www.europarl,europea.eu/portal/en.>

10 Grande, Edgar and Zangl, Bernhard, Varieties of Preventive Governance in World Risk Society (Ludwig-Maximilians-Universität München: Geschwister Scholl-Institut für Politikwissenschaft, 2011)Google Scholar.

11 Ian Bartle, “Risk-based Regulation and Better Regulation in the UK”, presentation held at the 2nd Biennial Conference of the ECPR Standing Group on Regulatory Governance, Utrecht University, 5–7 June 2008.

12 Moss, David, When All Else Fails. Government as the Ultimate Risk Manager (Cambridge, Mass.: Harvard University Press 2002)Google Scholar; Levi-Faur, Daniel, “Regulation & Regulatory Governance”, 2 Jerusalem Papers in Regulation & Governance (February 2010), pp. 147 Google Scholar; Büthe, Tim and Mattli, Walter, The New Global Rulers. The Privatization of Regulation in the World Economy (Princeton, NJ: Princeton University Press 2011)Google Scholar; Drezner, Daniel, All Politics is Global. Explaining International Regulatory Regimes (Princeton, NJ: Princeton University Press 2007)Google Scholar; Pollack, Mark A. and Shaffer, Gregory C., When Government Fails. The International Law and Politics of Genetically Modified Foods (Oxford: Oxford University Press 2009), pp. 235 et sqq CrossRefGoogle Scholar.

13 Wessel, Ramses A. and Wouters, Jan, “The Phenomenon of Multilevel Regulation: Interaction between Global, EU and National Regulatory Spheres. Towards A Research Agenda”, in Follesdal, Andreas, Wessel, Ramses A. and Wouters, Jan (eds), Multilevel Regulation and the EU. The Interplay between Global, European and National Normative Processes (Leiden and Boston: Martinus Nijhoff Publishers 2008), pp. 9 et sqq Google Scholar; Chowdhury, Nupur and Wessel, Ramses A., “Conceptualising Multilevel Regulation in the EU: A Legal Translation of Multilevel Governance?18(3) European Law Journal (2012), pp. 335 et sqq CrossRefGoogle Scholar.

14 Steinmo, Sven, Thelen, Katherine and Longstreth, Frank, Structuring Politics. Historical Institutionalism in Comparative Perspective (Cambridge: Cambridge University Press 1992)CrossRefGoogle Scholar; Powell, Walter W. and DiMaggio, Paul J., The New Institutionalism in Organizational Analysis (Chicago: University of Chicago Press 1991)Google Scholar.

15 The so-called MEDDEV Guidance Documents are a case in point, they are Commission documents and are agreed upon by the national medical device chiefs meeting as Medical Device Expert Groups (MDEG), a Commission body. Although not legally binding, they express the consensus among the national device chiefs, Commission staff, Eucomed and the Notified Body Expert Group (NBEG) about the interpretation of particular issues, but national courts may interpret MEDDEVs differently.

16 Daniel Carpenter, supra note 1; Marcia Angell, “The FDA. This Agency Can Be Dangerous”, New York Review of Books, 30 September 2011, at pp. 66–68.

17 David DeMortain in his review of Carpenter's 900-page opus magnum applauds him for his “untiring exploitation of archives and publications, great narrative skills, and capacity for elegant theorizing” while also raising critical issues about Carpenter’s failure to deal with the FDA's decline of reputation in recent years, the one-sided understanding of conceptual power, and his failure to acknowledge “the variety of ways in which concepts are put in practice across the world and indeed transformed as they diffuse”, DeMortain, David, “Review of David Carpenter’s Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA”, 25(2) Governance (2012), pp. 347 et sqq CrossRefGoogle Scholar.

18 Kahan, Jonathan S., Medical Device Development: Regulation and Law (Needham, MA: Barnett Educational Services 2009)Google Scholar; Reiss, John B. (ed.), Bringing Your Medical Device to Market, 3rd ed. (Washington D.C.: The Food and Drug Law Institute 2013)Google Scholar.

19 References to legal texts of the Commission are available on the Internet at: <ec.europea.eu/enterprise/policies/single-market> (last accessed on 11 May 2013).

20 Baldwin, Robert, Cave, Martin and Lodge, Martin, Understanding Regulatory Theory, Strategy and Practice, 2nd ed. (Oxford: Oxford University Press 2012)Google Scholar.

21 Organization for Economic Cooperation and Development, Recommendation of the Council on Regulatory Policy and Governance (Paris: OECD 2012)Google Scholar, available on the Internet at: <www.oecd.orgdoumentprint> (last accessed on 5 April 2012).

22 Over 500,000 different medical devices are on the market. Many are combination products which experts divide into three groups: (i) a device that combines devices and drugs (e.g. drug eluting stent where the medical device is key or a prefilled syringe where the drug is key); (ii) medical devices and in-vitro diagnostics (e.g. a specimen testing device where the medical device is primary agent; or a pregnancy test where the IVD plays that role); (iii) different medical devices in which several devices are combined in one implant (e.g. implantation pump).

23 Commission Directive 2005/50/EC on the Reclassification of Hip, Knee and Shoulder Joint Replacements in the Framework of Council Directive 93/42/EEC Concerning Medical Devices, OJ L 210/41; Directive 2003/12/EC on the Reclassification of Breast Implants in the Framework of Directive 93/42/EEC Concerning Medical Devices, OJ L 28/43.

24 Barry Meier regularly informs about the FDA and medical devices in The New York Times.

25 Institute of Medicine, supra note 3.

26 Vogel, David, The Politics of Precaution. Regulating Health, Safety, and Environment (Princeton, NJ: Princeton University Press 2012)Google Scholar; Vogel, David and Swinnen, Johan F. M., Transatlantic Regulatory Cooperation. The Shifting Roles of the EU, the US and California (Cheltenham, Mass.: Edward Elgar Publishing 2011)Google Scholar; Wiener, Jonathan and Rogers, Michael D., “Comparing Precaution in the United States and Europe”, 5(4) European Journal of Risk Research (2002), pp. 317 et sqq CrossRefGoogle Scholar.

27 Vogel, supra note 26 at p. 276.

28 Sorenson, Corinna and Drummond, Michael, “Socioeconomic Value of Orthopedic Devices: Evidence and Methodological Challenges”, 4 Orthopedic Research and Reviews (2012), pp. 87 et sqq.CrossRefGoogle Scholar

29 The National Institutes of Health defines regulatory science as: “the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, quality, potency and performance, and the role of what is a specialized and interdisciplinary area of biomedical research than can generate new knowledge and tools for assessing experimental therapies, preventive therapies and diagnostics”. Ashley Yeo, “The Regulator's Chance to Catch Up with Science”, available on the Internet at: <raj.com/productsector/medicaldevices> (received on 28 May 2012); Food and Drug Administration (FDA), “Regulatory Science in FDA's Center for Devices and Radiological Health. A Vital Framework for Protecting and Promoting Public Health” (UCM 274162, created on 26 September 2011, modified on 5 October 2011).

30 Franklin, Gary M. and Budenholzer, Brian R., “Implementing Evidence-Based Health Policy in Washington State”, 362(18) N Engl J Med (2009), pp. 1722 et sqq CrossRefGoogle Scholar.

31 Agency for Healthcare Research and Quality, Advances in Patient Safety: From Research to Implementation, available on the Internet at: <www.arhqgov/legacy/qual/advaces/index.html> (last accessed on 5 June 2013).

32 David B. Caruso, “US Has No Good System to Track Medical Implants”, Associated Press, 5 October 2009, available on the Internet at: <phys.org/news173974663.html> (last accessed on 8 June 2013).

33 Resnic, Frederic S., and Normand, Sharon-Lise T., “Postmarketing Surveillance of Medical Devices – Filling in the Gaps”, 366 (10) N Engl J Med (2012), pp. 875 et sqq, at p. 876CrossRefGoogle ScholarPubMed.

34 William Maisel, M.D., M.P.H. Deputy Director for Science, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services, Before the Senate Special Committee on Aging, United States Senate, “A Delicate Balance: FDA and the Reform of the Medical Device Approval Process”, April 13, 2011, pp. 120 et sqq, at pp. 134–135.

35 Sharma, Arjun, Blank, Anthony, Patel, Parashar, and Stein, Kenneth, “Health Care Policy and Regulatory Implications on Medical Device Innovations: A Cardiac Rhythm Medical Device Industry Perspective”, 36 J Interv Card Electrophysiol (2013), pp. 107 et sqq, DOI/10.1007/s10840-013-9781-yCrossRefGoogle ScholarPubMed.

36 Kahan, supra note 18.

37 Commission Proposal for a Regulation of the European Parliament and of the Council on Medical Devices and Amending Directive 2001/82/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, (COM(2012) 542.

38 Commission Proposal for a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, (COM(2012) 541 final.

39 Amanda Maxwell, “Third Way Surfaces in EU Medtech Regulatory Reform Debate”, 17 May 2013, available on the Internet at: <www.rajpharma.com/productsector/medicaldevices/> (downloaded on 21 May 2013).

40 European Parliament Committee on the Environment, Public Health and Food Safety, Rapporteur: Dagmar Roth-Behrendt, MEP (S&D, Germany), Draft Report on the Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. COM(2012)0542 – C7-0318/2012 – 2012 /0266(COD); Rapporteur: Peter Liese (MEP, EEP, Germany), Draft Report on the Proposal for a Regulation of the European Parliament and of the Council on In Vitro Diagnostic Medical Devices, 3 April 2013, available at the Internet at: <www.europarl.europa.eu/sides/get-Doc.do?pubRef=2f%2fEP%%2f%2fNONSGML%2bCOMPAAARL%2bPE-506.196%2b01%2bDOC%2bPDF%2bV0%2f%2fEN> (last accessed on 30 April 2013).

41 Under the Lisbon Treaty (2009) new legislation has to be adopted respecting “non-legislative acts”, which can be “delegated acts” or “implementing acts.” These acts need to be defined before EU-level committees of national device chiefs, scientific-academic experts and Commission staff can take up their work.

42 Eucomed Medical Technology, “Position Paper. Towards a Regulation That Guarantees Patient Safety, Ensures Patient Access and Keeps Innovation in Europe. Eucomed's Response to the Commission's Proposal for the Revision of the EU Medical Device Directive”, 30 January 2013, available on the Internet at: <eucomed.org/key-themes/medical-devices-directives> (downloaded on 29 April 2013). On the IVDR, see Jesus Rueda Rodriguez, “Industry's View on the Future of In Vitro Diagnostic (IVD) Legislation in Europe”, 10 May 2013, available on the Internet at: <medtecheurope.org/newsletternews/218/86>.

43 Art. 97(1) of the proposed Medical Device Regulation; and Art. 90(2) of the proposed In Vitro Diagnostic Medical Device Regulation, supra note 37.

44 510(k) refers to the article in the 1976 legislation.

45 Hodges, Christopher, “Do We Need a Medical Devices Agency?”, 12(3) Medical Law Review (2004), pp. 268 et sqq CrossRefGoogle Scholar; Jackson, Emily, “The Regulation of Medicinal Products and Medical Devices”, in Grubb, Andrew, Laing, Judith and McHale, Jean (eds), The Principles of Medical Law (Oxford: Oxford University Press 2011)Google Scholar; Majone, Giandomenico, “Foundations of Risk Regulation: Science, Decision-Making, Policy Learning and Institutional Reform”, 1 EJRR (2010), pp. 5 et sqq Google Scholar. Majone is an advocate of EU agencies American style.

46 Alan G. Fraser, Jean-Claude Daubert, Frans de Werf, Mark Estes 3rd, Sidney C. Smith Jr, Mitchell W. Krucoff, Panos E. Vardas, and Michel Komajda, on behalf of the participants/ “Clinical Evaluation of Cardiovascular Devices: Principles, Problems, and Proposals for European Regulatory Reform. Report of a Policy Conference of the European Society of Cardiology” European Heart Journal (2011) 32, 1673 et sqq, Doi:10.1093/eurheartj/ehr171.

47 Cohen, Deborah and Billingsley, Matthew, “Europeans Are Left to Their Own Devices”, 342 BMJ (2011;342:d2748doi:10.1136/bmj.d2748), pp. 1 et sqq Google ScholarPubMed.

48 European Parliament Press release, “Health MEPs Call For Stricter Controls on Medical Devices”, 25 September 2013, available on the Internet at: www.europarl.europa.eu/news/en/news-room/content/20130923IPR20607/html/Health-MEPs-call-for-stricter-controls-on-medical-devices; European Parliament Committee on the Environment, Public Health and Food Safety, ENVI(2013)0925_1. Draft Agenda, OJ\PE519526v02-00en.rtf PE519.526v02-00.

49 Francois-Regis Babinet and Peter Bogart, “Innovation vs. Safety: The New Proposed Rules for Medical Devices in the European Union”, Update, The Food and Drug Law Institute, January/February 2013, available on the Internet at: <www.fdli.org.>; Nupur Chowdhury, “Pursuing Legal Certainty in Multilevel Regulation. A Socio-legal Study of Medical Device & Pharmaceutical Regulation in Europe” (doctoral thesis on file at the University of Twente, 2013).

50 House of Commons Science & Technology Committee (STC), “Regulation of Medical Implants in the EU and UK”, 1 November 2012, available on the Internet at: <www.publications.parliament/uk/pa/cm/201213/cmselect/cmsctech/163/16393.htm> (downloaded on 5 November 2012).

51 Eucomed, “Rushed Deal Leaves Patients and Jobs in Second Place”, Press Release of 25 September 2013, available from: thenewsroom@euromed.org (received on 25 September 2013).

52 Paul Van de Water, “Excise Tax on Medical Devices Should Not Be Repealed. Industry Lobbyists Distort Tax's Impact”, Updated 2 October 2013, Center on Budget and Policy Priorities, Washington, DC, available on the Internet at: <www.cbpp.org/cms/?fa=view&id=3684> (downloaded on 3 October 2013).

53 Barry Meier, “Medical Device Industry Fears Law's Tax on Sales,” The New York Times, 1 October 2013, at p. A14.

54 The formal position of the Medical Device Manufacturers Association (MDMA) is available on the Internet at: <www.medicaldevices.org/issues/Health-Care-Reform,-Device-Tax>; Elizabeth Warren, the consumer advocate, rejects the tax, available on the Internet at: <abcnews.go.com/blogs/politics/2012/09/whyelizabeth-warren-wants-to-repeal-part-of-obamacare/> and <www.massdevice.com/blogs/massdevice/mass-sen-hopeful-elizabeth-warren-device-tax-fda-and-climate-innovation>.

55 Pricewaterhouse Coopers (PwC), “Medical Technology Innovation Scorecard: The Race for Global Leadership”, January 2011.

56 Institute of Medicine, supra note 3, at pp. 16–17.

57 Grant Castle and Robin Blaney, “European Union Regulation of In Vitro Diagnostic Medical Devices”, in Scott D. Danzis and Ellen Flannery (eds), In Vitro Diagnostics: The Complete Regulatory Guide (Washington, D.C.: The Food and Drug Law Institute, 2010), at pp. 231–232.

58 Ibid., at p. 231.

59 Institute of Medicine, Public Health Effectiveness of the FDA 510(k) Clearance Process. Balancing Patient Safety and Innovation (Washington, D.C.: The National Academies Press, 2011)Google ScholarPubMed; Wright, Elisabeth Ann and Datlof, Steven B., “Adverse Event Reporting in the EU and the US. Similarities and differences”, 7(3) Journal of Medical Device Regulation (2010), pp. 14 et sqq Google Scholar.

60 Commission Decision on Common Technical Specifications for In Vitro-Diagnostic Medical Devices, OJ L 131/17; Commission Decision Amending Decision 2002/364/EC Common Technical Specifications for In Vitro-Diagnostic Medical Devices, OJ L 318/25; Compendium to Commission Decision 2009/886/EC, OJ L 348/94.

61 This co-regulation instrument was used historically in some EU Member States prior to its incorporation into the legal system of the single market.

62 Nupur Chowdury, “Common Market But Divergent Regulatory Practices: Exploring European Regulation and The Effect on Regulatory Uncertainty in The Marketing Authorization of Medical Products”, Journal of European Integration (2012), DOI:10.1080/07036337.2012.711825, available on the Internet at: <www.tandonline.com7loi/geui20> (last accessed on 8 June 2013).

63 Statement of Jeffrey Shuren, M.D., J.D. Director, Center for Devices and Radiological Health, Food and Drug Administration, Department of Health and Human Services Before the Subcommittee on Health, Committee on Energy and Commerce, U.S. House of Representatives, 17 February 2011, available on the Internet at: <www.fda.gov/NewsEvents/Testimony/ucm243716.htm> (downloaded on 5 April 2013); for more details of U.S. perspectives on the EU system, see “FDA User Fees 2012: How Innovation Helps Patients and Jobs (JS).” Statement by Jeffrey Shuren, M.D., J.D. Director, Center for Devices and Radiological Health. Food and Drug Administration, Department of Health and Human Services Before the Subcommittee on Health. Committee on Energy and Commerce. U.S. House of Representatives, 18 April 2012, available on the Internet at: <www.fda.gov/NewsEvents/Testimony> (downloaded on 5 April 2013).

64 Center for Devices and Radiological Health. U.S. Food and Drug Administration, “Strengthening Our National System for Medical Device Postmarket Surveillance. Update and Next Steps”, April 2013, available on the Internet at: <www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf> (downloaded on 29 April 2013).

65 Liz Fuller, “Transparency Policies at the US FDA”, 26 October 2012, available on the Internet at: <www.rajpharma.com> (received on 29 October 2012).

66 On 14 June 2012, the European Parliament voted on a pharmastyle regulation for medical devices. The report by ENVI submitted on 12 April 2013, by Dagmar Roth-Behrend, rapporteur of ENVI, upheld this recommendation.

67 Steven Bridges, “Medical Devices in the EU Spotlight”, 18 December 2012, available on the Internet at: <www.rajcom> (downloaded on 19 December 2012), pp. 1–2.

68 Congressional hearings, supra note 8.

69 Maisel, William H., “Medical-Device Safety and the FDA (correspondence)”, 358 N Engl J Med (3 July 2008), pp. 88 et sqq (downloaded on 24 March 2012)Google Scholar; Maisel, William H., “Semper Fidelis – Consumer Protection for Patients with Implanted Medical Devices”, 358(10) N Engl J Med (6 March 2008), pp. 985 et sqq (downloaded on 24 March 2012)CrossRefGoogle ScholarPubMed; Maisel, W.H. and Kohno, T., “Improving the Security and Privacy of Implantable Medical Devices, 362(13) N Engl J Med (2010), pp. 1164 et sqq CrossRefGoogle ScholarPubMed; Makow, Lawrence S., “Medical Device Review at the Food and Drug Administration: Lessons from Magnetic Resonance Spectroscopy and Biliary Lithropsy”, 46 Stanford Law Review, pp. 709 et sqq CrossRefGoogle Scholar; Challoner, David R. and Vodra, William W., “Medical Devices and Health – Creating a New Regulatory Framework for Moderate Risk-Devices”, 365(11) N Engl J Med (2011), pp. 977 et sqq CrossRefGoogle ScholarPubMed, Curfman, Gregory D. and Redberg, Rita, “Medical Devices – Balancing Regulation and Innovation”, 365(11) N Engl J Med (2011), pp. 975 et sqq CrossRefGoogle ScholarPubMed.

70 General Accounting Office, Shortcomings in FDA's Premarket Review, Postmarket Surveillance and Inspections of Device Manufacturing Establishments (Washington, D.C. GAO-0937OT, 2009).

71 Josh Makower, M.D.with support from Medical Device Manufacturers Association (MDMA), National Capital Association (NCA) and multiple State medical industry organizations, “FDA Impact on U.S. Medical Technology Innovation. A Survey of Over 200 Medical Technology Companies”, November 2010, pp. 20 et sqq, available on the Internet at: <www.medtechEurope.org/newsletternews/203/86> (downloaded on 29 April 2013).

72 Okie, Susan, “Reviving the FDA”, 363(16) N Engl J Med (2010), pp. 1492 et sqq (downloaded on 9 October, 2011)CrossRefGoogle Scholar ; Voelker, Rebecca, “FDA Ponders Regulation and Innovation”, 35(15) JAMA (2011), pp. 1523 et sqq (downloaded on 25 March 2012)CrossRefGoogle Scholar; Zuckerman, Diana, “Do Conflicts of Interest Undermine FDA Approval Decisions?”, 16(5) Regulatory Affairs Journal Devices (2008), pp. 309 et sqq Google Scholar; Diana Zuckerman, Paul Brown and Steven E. Nissen, “Medical Device Recalls and the FDA Approval Process”. Reprinted, Arch Intern Med published online, 14 February 2011, available on the Internet at: <www.archinternmed.com> (downloaded on 21 April 2011).

73 Institute of Medicine, supra note 3, at p. 204.

74 Mitchell D. Feldman, Amy J. Petersen, Leah S. Karliner and Jeffrey A. Tice, “Who is Responsible for Evaluating the Safety and Effectiveness of Medical Devices? The Role of Independent Technology Assessment”, 23 Suppl. 1 J Gen Intern Med 23 (2007) (DOI: 10.1007/s11606-007-0275-4), pp. 57 et sqq, at p. 57.

75 Institute of Medicine, supra note 3, at p. 87.

76 Ibid., at p. 3 and p. 87.

77 Ibid., at p. 89.

78 Korobkin, Russell, “Who Should Protect the Public? The Supreme Court and Medical Device Regulation”, 357(17) N Engl J Med (2007), pp. 1680 et sqq CrossRefGoogle ScholarPubMed; Garber, Alan M., “Modernizing Device Regulation”, 362(13) N Engl J Med. (2010), pp. 1161 et sqq CrossRefGoogle ScholarPubMed.

79 Okie, supra note 72; Zuckerman, Brown and Nissen, supra note 72.

80 David R. Challoner, Chair, Committee on the Public Health Effectiveness of the FDA (510(k) Clearance Process, Letter to Dr. Shuren, Director, CDHR, 20 July 2011; Institute of Medicine, supra note 4.

81 This irrespective of what global harmonization might mean in the global context and a definition of “good clinical practice,” “clinical evidence” and good “regulatory science” they and FDA have worked and agreed on in the Global Harmonization Task Force (GHTF 2007) between 1992 and 2012.

82 United States International Trade Commission (USITC), Medical Devices and Equipment: Competitive Conditions Affecting U.S. Trade in Japan and Other Principal Foreign Markets (Washington, D.C: USITC Publication 3909, 2007).

83 The GHTF was a joint regulator-industry forum from 1992 to March 2012 when it was replaced by a regulatory-only forum, the International Medical Device Regulators Forum (IMDRF).

84 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

85 FDA Advisory Committees, available on the Internet at: <www.fda.gov/AdvisoryCommittees/CommmitteesMeetingMaterials/MedicalDevices> (last accessed on 14 April 2013).

86 In Europe, scientific input to drug regulation is channelled to the European Medicinal Agency, while numerous EU-level expert committees and three scientific committees on emerging and newly identified health risks (SCENIHR), on consumer safety (SCCs) and health and environmental risks (SCHER) are directly reporting to the Commission. Commission Decision Setting Up an Advisory Structure of Scientific Committees and Experts in the Field of Consumer Safety, Public Health and the Environment and Repealing Decision 2004/210/EC, OJ 2008 L 241/21.

87 Congressional hearings, supra note 8.

88 Dr. Shuren's spoken words, 2011.

89 Daniel Schultz, Director, CDRH, “PMS Transformation. Connecting the Dots”, presentation held at the GHTF 2006 Conference, Lübeck, 28–30 June 2006.

90 Vibha Sharma, “US Medical Device User Fee Programme Edges Closer to Implementation”, 19 March 2012, available on the Internet at: <www.rajpharma.com> (received on 21 March 2012).

91 Kramer, Daniel B., Xu, Shuai and Kesselheim, Aaron S., “Regulation of Medical Devices in the United States and European Union”, 366 N Engl J Med (2012), pp. 848 et sqq, at p. 8CrossRefGoogle ScholarPubMed.

92 Jennifer D. Newberger, “New Guidance from the US FDA May Mean Just One Thing for Medical Device Manufacturers – More 510(k)”, 1 August 2011, available on the Internet at: <www.rajpharma.com> (received on 1 August 2011).

93 Institute of Medicine, supra note 4 and note 50; Institute of Medicine, Public Health Effectiveness of the FDA 510(k) Clearance Process. Balancing Patient Safety and Innovation. Workshop Report, Wizemann, Theresa (ed.), (Washington, D.C.: The National Academies Press, 2010)Google Scholar.

94 Challoner, supra note 80, at p. 2.

95 Meaghan Bailey and Jack Kent, “The IOM Report on the 510(k) Clearance Process in the US: A Starting Point for Debate”, available on the Internet at: <www.rajpharma.com/productsector/medicaldevices/> (received on 13 September 2011), at p. 1.

96 Bailey and Kent, supra note 95, at p. 1.

97 AdvaMed, “Statement on IOM Report 510(k)”, Press Release, 29 July 2011, available on the Internet at: <www.advamed.org.com>.

98 Challoner, supra note 80, at p. 2.

99 The two workshops were convened by the IOM and had a wide participation of academics representing a cross-section of expertise and knowledge, staff of the FDA and industry representatives. They provided information and presented commissioned papers. The final recommendations were approved by the 12-member Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process. In addition, fourteen reviewers and experts reviewed the final recommendations supervised by two experts (one from industry and one academic) appointed by the National Research Council.

100 These are The Advanced Medical Technology Association (AdvaMed), the Medical Device Manufacturers Association (MDMA) and the Medical Imaging Technology Association (MITA).

101 FDA, “Understanding Barriers to Medical Device Quality”, 31 October 2011, available on the Internet at: <www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf.>

102 Statement by Jeffrey Shuren, M.D., J.D. Director, Center for Devices and Radiological Health, FDA, Department of Health and Human Services, Before the Subcommittee on Health of the Committee on Energy and Commerce, U.S. House of Representation, 18 April, 2012. This hearing produced extensive comments on specific reforms.

103 Stewart Eisenhart, “FDA Unveils Elements of 510(k) Overhaul. Postpones Hot-button Issues”, available from StewartEisenhart@ Emergo.Group.com (received on 1 January 2011).

104 For an update of FDA's efforts, see William Maisel, supra note 34.

105 Donna Young, “US Senate Adopts FDA User Fee Bill in Rare Bipartisan Move”, 25 May 2012, available on the internet at: <www.rajpharma.com> (received on 28 May 2012).

106 Representative Joe Pitts held a Hearing on Reauthorization Medical Device User Fee Act, 15 February 2012.

107 Vibha Sharma, “US FDA Consults on Creating External Expert Network for Emerging Medical Devices”, available on the Internet at: <www.rajpharma.com> (received on 5 May 2011).

108 Vibha Sharma, “New Bills in US House, Senate Aim to Streamline FDA Device Reviews”, available on the Internet at: <www.rajpharma.com> (received on 20 October 2011).

109 Comments by Public Citizen's Health Research Group on FDA 510(k) Medical Devices Working Group Preliminary Report and Recommendations authored by Jonas Zajac Hines, Peter Lurie, Eunice Yu, Sidney Wolfe, “Left to Their Own Devices: Breakdowns in the United States Medical Device Premarket Review”, 7/7 PloS Medicine (2010), available on the Internet at: <www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000280> (last accessed on 8 June 2013).

Send article to Kindle

To send this article to your Kindle, first ensure no-reply@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle.

Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States
Available formats
×

Send article to Dropbox

To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Dropbox.

US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States
Available formats
×

Send article to Google Drive

To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your <service> account. Find out more about sending content to Google Drive.

US Perspectives on the EU Medical Device Approval System, and Lessons Learned from the United States
Available formats
×
×

Reply to: Submit a response

Please enter your response.

Your details

Please enter a valid email address.

Conflicting interests

Do you have any conflicting interests? *