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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
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.
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- Symposium on the EU's New Medical Devices Regulatory Framework
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- Copyright © Cambridge University Press 2013
References
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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.
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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.
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58 Ibid., at p. 231.
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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.
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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).
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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.
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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.
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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).