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Volumn 1, Issue 5, 2016, Pages 399-412

Drugs and Devices: Comparison of European and U.S. Approval Processes

Author keywords

device approval; drug approval; EMA; European Commission; FDA

Indexed keywords


EID: 85002715026     PISSN: 2452302X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jacbts.2016.06.003     Document Type: Article
Times cited : (187)

References (84)
  • 1
    • 84882735162 scopus 로고    scopus 로고
    • Comparison of drug approval process in United States and Europe
    • 1 Kashyap, U.N., Gupta, V., Raghunandan, H.V., Comparison of drug approval process in United States and Europe. J Pharm Sci Res 5 (2013), 131–136.
    • (2013) J Pharm Sci Res , vol.5 , pp. 131-136
    • Kashyap, U.N.1    Gupta, V.2    Raghunandan, H.V.3
  • 2
    • 84920842586 scopus 로고    scopus 로고
    • Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments
    • 2 Wild, C., Erdos, J., Zechmeister, I., Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments. BMC Cardiovasc Disord, 14, 2014, 154.
    • (2014) BMC Cardiovasc Disord , vol.14 , pp. 154
    • Wild, C.1    Erdos, J.2    Zechmeister, I.3
  • 3
    • 84857885489 scopus 로고    scopus 로고
    • Regulation of medical devices in the United States and European Union
    • 3 Kramer, D.B., Xu, S., Kesselheim, A.S., Regulation of medical devices in the United States and European Union. N Engl J Med 366 (2012), 848–855.
    • (2012) N Engl J Med , vol.366 , pp. 848-855
    • Kramer, D.B.1    Xu, S.2    Kesselheim, A.S.3
  • 4
    • 85002724770 scopus 로고    scopus 로고
    • Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. Washington, DC: National Academies Press, 2011. Available at: Accessed June 3
    • 4 Institute of Medicine. Medical Devices and the Public's Health: the FDA 510(k) Clearance Process at 35 Years. Washington, DC: National Academies Press, 2011. Available at: http://www.nationalacademies.org/hmd/∼/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf. Accessed June 3, 2016.
    • (2016)
  • 5
    • 85002872999 scopus 로고    scopus 로고
    • Bill Wants Drugs Approved in Europe to Be Available More Quickly to US Patients. Regulatory Focus March 15, 2015. Regulatory Professional Affairs Society. Available at: Accessed May 28
    • 5 Gaffney A. Bill Wants Drugs Approved in Europe to Be Available More Quickly to US Patients. Regulatory Focus March 15, 2015. Regulatory Professional Affairs Society. Available at: http://www.raps.org/Regulatory-Focus/News/2015/03/20/21778/Bill-Wants-Drugs-Approved-in-Europe-to-be-Available-More-Quickly-to-US-Patients/. Accessed May 28, 2016.
    • (2016)
    • Gaffney, A.1
  • 6
    • 84896697554 scopus 로고    scopus 로고
    • Regulation of medicines and medical devices: contrasts and similarities
    • 6 Parvisi, N., Woods, K., Regulation of medicines and medical devices: contrasts and similarities. Clin Med 14 (2014), 6–12.
    • (2014) Clin Med , vol.14 , pp. 6-12
    • Parvisi, N.1    Woods, K.2
  • 7
    • 85010297644 scopus 로고    scopus 로고
    • Drugs, devices and the FDA: an overview of approval processes. Part 1 FDA approval processes for drugs
    • 7 Van Norman, G.A., Drugs, devices and the FDA: an overview of approval processes. Part 1 FDA approval processes for drugs. J Am Coll Cardiol Basic Trans Science 1 (2016), 170–179.
    • (2016) J Am Coll Cardiol Basic Trans Science , vol.1 , pp. 170-179
    • Van Norman, G.A.1
  • 8
    • 85009350742 scopus 로고    scopus 로고
    • Drugs, devices and the FDA: an overview of approval processes. Part 2 FDA approval of medical devices
    • 8 Van Norman, G.A., Drugs, devices and the FDA: an overview of approval processes. Part 2 FDA approval of medical devices. J Am Coll Cardiol Basic Trans Science 1 (2016), 277–287.
    • (2016) J Am Coll Cardiol Basic Trans Science , vol.1 , pp. 277-287
    • Van Norman, G.A.1
  • 9
    • 85002558572 scopus 로고    scopus 로고
    • Drug Administration. History. Available at: Accessed March 4
    • 9 U.S. Food and Drug Administration. History. Available at: http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm. Accessed March 4, 2016.
    • (2016)
    • Food, U.S.1
  • 10
    • 85002834943 scopus 로고    scopus 로고
    • U.S. Government Accountability Office. Classes of Devices. Publication No. 21 USC 360c(a);2006 ed. Washington, DC: U.S. Government Printing Office
    • 10 U.S. Government Accountability Office. Classes of Devices. Publication No. 21 USC 360c(a);2006 ed. Washington, DC: U.S. Government Printing Office, 2006.
    • (2006)
  • 11
    • 85002761186 scopus 로고    scopus 로고
    • Drug Administration. Medical Device User Fee and Modernization Act (MDUFA). Available at: Accessed June 3
    • 11 U.S. Food and Drug Administration. Medical Device User Fee and Modernization Act (MDUFA). Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/default.htm. Accessed June 3, 2016.
    • (2016)
    • Food, U.S.1
  • 12
    • 85002945292 scopus 로고    scopus 로고
    • Council Directive 65/65/EEC of 26 January 1965 on the Approximation of Provisions Laid Down by Law, Regulation or Administrative Action Relating to Proprietary Medicinal Products. Available at: Accessed May 27
    • 12 Council Directive 65/65/EEC of 26 January 1965 on the Approximation of Provisions Laid Down by Law, Regulation or Administrative Action Relating to Proprietary Medicinal Products. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31965L0065 Accessed May 27, 2016.
    • (2016)
  • 13
    • 85002979659 scopus 로고    scopus 로고
    • Drug Administration. A Look at the European Medicines Agency. Available at: Accessed June 3
    • 13 U.S. Food and Drug Administration. A Look at the European Medicines Agency. Available at: http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHealthLiteracy/ucm246776.htm. Accessed June 3, 2016.
    • (2016)
    • Food, U.S.1
  • 14
    • 85002697590 scopus 로고    scopus 로고
    • European Commission. Clinical Trials – Directive 2001/20/EC. Available at. Accessed June 3
    • 14 European Commission. Clinical Trials – Directive 2001/20/EC. Available at http://ec.europa.eu/health/human-use/clinical-trials/directive/index_en.htm. Accessed June 3, 2016.
    • (2016)
  • 15
    • 85002599224 scopus 로고    scopus 로고
    • European Commission. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC. Available at: Accessed June 17
    • 15 European Commission. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use, and Repealing Directive 2001/20/EC. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf. Accessed June 17, 2016.
    • (2016)
  • 16
    • 85002934666 scopus 로고    scopus 로고
    • European Medicine's Agency. Orphan Designation. Available at: Accessed June 3
    • 16 European Medicine's Agency. Orphan Designation. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000029.jsp. Accessed June 3, 2016.
    • (2016)
  • 17
    • 85002580978 scopus 로고    scopus 로고
    • Drug Administration. Developing Products for Rare Diseases & Conditions. Available at: Accessed June 17
    • 17 U.S. Food and Drug Administration. Developing Products for Rare Diseases & Conditions. Available at: http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm. Accessed June 17, 2016.
    • (2016)
    • Food, U.S.1
  • 18
    • 85002960265 scopus 로고    scopus 로고
    • European Medicines Agency. Guideline on the Scientific Application and the Practical Arrangements Necessary to Implement Commission Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use Falling Within the Scope of Regulation (EC) No 726/2004. Available at: Accessed June 3
    • 18 European Medicines Agency. Guideline on the Scientific Application and the Practical Arrangements Necessary to Implement Commission Regulation (EC) No 507/2006 on the Conditional Marketing Authorisation for Medicinal Products for Human Use Falling Within the Scope of Regulation (EC) No 726/2004. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/03/WC500202774.pdf. Accessed June 3, 2016.
    • (2016)
  • 19
    • 85002957328 scopus 로고    scopus 로고
    • European Medicines Agency. About Us. Available at: Accessed June 3
    • 19 European Medicines Agency. About Us. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000235.jsp&mid. Accessed June 3, 2016.
    • (2016)
  • 20
    • 33845937823 scopus 로고    scopus 로고
    • Review of UK Health Research Funding
    • Her Majesty's Stationery Office London, UK Accessed June 3, 2016
    • 20 Cooksey, D.A., Review of UK Health Research Funding. 2006, Her Majesty's Stationery Office, London, UK https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/228984/0118404881.pdf Accessed June 3, 2016.
    • (2006)
    • Cooksey, D.A.1
  • 21
    • 84862239891 scopus 로고    scopus 로고
    • Regulatory review of novel therapeutics—comparison of three regulatory agencies
    • 21 Downing, N.S., Aminawung, J.A., Shah, N., et al. Regulatory review of novel therapeutics—comparison of three regulatory agencies. N Engl J Med 366 (2012), 2284–2293.
    • (2012) N Engl J Med , vol.366 , pp. 2284-2293
    • Downing, N.S.1    Aminawung, J.A.2    Shah, N.3
  • 22
    • 79960238308 scopus 로고    scopus 로고
    • Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe
    • 22 Roberts, S.A., Allen, J.D., Sigal, E.V., Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe. Health Aff (Millwood) 30 (2011), 1375–1381.
    • (2011) Health Aff (Millwood) , vol.30 , pp. 1375-1381
    • Roberts, S.A.1    Allen, J.D.2    Sigal, E.V.3
  • 23
    • 0000385491 scopus 로고
    • Publication bias: a problem in interpreting medical data
    • 23 Begg, C.B., Berlin, J.A., Publication bias: a problem in interpreting medical data. J R Stat Soc 151 (1988), 419–463.
    • (1988) J R Stat Soc , vol.151 , pp. 419-463
    • Begg, C.B.1    Berlin, J.A.2
  • 24
    • 85002810383 scopus 로고    scopus 로고
    • Drug Administration. Drugs @ FDA: FDA Approved Drug Products.. Accessed June 3
    • 24 U.S. Food and Drug Administration. Drugs @ FDA: FDA Approved Drug Products. https://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed June 3, 2016.
    • (2016)
    • Food, U.S.1
  • 25
    • 0037267022 scopus 로고    scopus 로고
    • How useful are unpublished data from the Food and Drug Administration in meta-analysis?
    • 25 MacLean, C.H., Morton, S.C., Ofman, J.J., Roth, E.A., Shekelle, P.G., How useful are unpublished data from the Food and Drug Administration in meta-analysis?. J Clin Epidem 56 (2003), 44–51.
    • (2003) J Clin Epidem , vol.56 , pp. 44-51
    • MacLean, C.H.1    Morton, S.C.2    Ofman, J.J.3    Roth, E.A.4    Shekelle, P.G.5
  • 26
    • 84855701883 scopus 로고    scopus 로고
    • Opening up data at the European Medicines Agency
    • 26 Gøtzsche, P.C., Jørgensen, A.W., Opening up data at the European Medicines Agency. BMJ, 342, 2011, d2686.
    • (2011) BMJ , vol.342 , pp. d2686
    • Gøtzsche, P.C.1    Jørgensen, A.W.2
  • 27
    • 84887887034 scopus 로고    scopus 로고
    • Regulation and safe adoption of new medical devices and procedures
    • 27 Campbell, B., Regulation and safe adoption of new medical devices and procedures. Brit Med Bull 107 (2013), 5–18.
    • (2013) Brit Med Bull , vol.107 , pp. 5-18
    • Campbell, B.1
  • 28
    • 0033380591 scopus 로고    scopus 로고
    • European medical device regulatory law and product liability
    • 28 Bright, J., European medical device regulatory law and product liability. J Hosp Infect 43 (1999), 169–173.
    • (1999) J Hosp Infect , vol.43 , pp. 169-173
    • Bright, J.1
  • 29
    • 85002846500 scopus 로고    scopus 로고
    • EUR-Lex. Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. Available at: Accessed May 27
    • 29 EUR-Lex. Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices. Available at: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:31993L0042. Accessed May 27, 2016.
    • (2016)
  • 30
    • 84895793436 scopus 로고    scopus 로고
    • Improving medical device regulation: the United States and Europe in perspective
    • 30 Sorenson, C., Drummond, M., Improving medical device regulation: the United States and Europe in perspective. Milbank Qrtly 92 (2014), 114–130.
    • (2014) Milbank Qrtly , vol.92 , pp. 114-130
    • Sorenson, C.1    Drummond, M.2
  • 31
    • 84887627609 scopus 로고    scopus 로고
    • Registration and regulation of medical devices used in diabetes in Europe: need for radical reform
    • 31 Boulton, A.J.M., Registration and regulation of medical devices used in diabetes in Europe: need for radical reform. Lancet Diabetes Endocrinol 1 (2013), 270–272.
    • (2013) Lancet Diabetes Endocrinol , vol.1 , pp. 270-272
    • Boulton, A.J.M.1
  • 32
    • 0035461507 scopus 로고    scopus 로고
    • The regulation of medical devices and the role of the Medical Devices Agency
    • 32 Jefferys, D.B., The regulation of medical devices and the role of the Medical Devices Agency. Br J Clin Pharmacol 52 (2001), 229–235.
    • (2001) Br J Clin Pharmacol , vol.52 , pp. 229-235
    • Jefferys, D.B.1
  • 33
    • 70149116778 scopus 로고    scopus 로고
    • Understanding the medical device directive changes
    • 33 McKenna, C., Understanding the medical device directive changes. Biomed Instrum Technol 43 (2009), 319–320.
    • (2009) Biomed Instrum Technol , vol.43 , pp. 319-320
    • McKenna, C.1
  • 34
    • 85002999628 scopus 로고    scopus 로고
    • European Commission. Market Surveillance and Vigilance. Eudamed—European Databank on Medical Devices. Available at. Accessed June 3
    • 34 European Commission. Market Surveillance and Vigilance. Eudamed—European Databank on Medical Devices. Available at http://ec.europa.eu/growth/sectors/medical-devices/market-surveillance/index_en.htm. Accessed June 3, 2016.
    • (2016)
  • 35
    • 85002844444 scopus 로고    scopus 로고
    • The Future of Eudamed—Better, Bigger, Riskier. EmergoGroup blog, February 1, 2016. Available at: Accessed June 3
    • 35 Boumans R. The Future of Eudamed—Better, Bigger, Riskier. EmergoGroup blog, February 1, 2016. Available at: http://www.emergogroup.com/blog/2016/02/future-eudamed-better-bigger-riskier. Accessed June 3, 2016.
    • (2016)
    • Boumans, R.1
  • 36
    • 0037412507 scopus 로고    scopus 로고
    • EU and member state medical device regulation
    • 36 Altenstetter, C., EU and member state medical device regulation. Int J Tech Assess Health Care 19 (2003), 228–248.
    • (2003) Int J Tech Assess Health Care , vol.19 , pp. 228-248
    • Altenstetter, C.1
  • 37
    • 85002972549 scopus 로고    scopus 로고
    • Global Legal Research Center. Approval of Medical Devices. The Law Library of Congress. September 2014. Available at: Accessed on June 3
    • 37 Global Legal Research Center. Approval of Medical Devices. The Law Library of Congress. September 2014. Available at: https://www.loc.gov/law/help/medical-devices/approval-of-medical-devices.pdf. Accessed on June 3, 2016.
    • (2016)
  • 38
    • 85002571022 scopus 로고    scopus 로고
    • European Commission. Guidelines on Medical Devices: Guidelines on Clinical Investigations; Guide for Manufacturers and Notified Bodies. MEDDEV 2.7/4. Available at: Accessed June 3
    • 38 European Commission. Guidelines on Medical Devices: Guidelines on Clinical Investigations; Guide for Manufacturers and Notified Bodies. MEDDEV 2.7/4. Available at: http://ec.europa.eu/DocsRoom/documents/10336/attachments/1/translations. Accessed June 3, 2016.
    • (2016)
  • 39
    • 84868028199 scopus 로고    scopus 로고
    • How a fake hip showed up failings in the European device regulation
    • 39 Cohen, D., How a fake hip showed up failings in the European device regulation. BMJ, 345, 2012, e7090.
    • (2012) BMJ , vol.345 , pp. e7090
    • Cohen, D.1
  • 40
    • 16544379129 scopus 로고    scopus 로고
    • Medical device development: from prototype to regulatory approval
    • 40 Kaplan, A.V., Baim, D.S., Smith, J.J., et al. Medical device development: from prototype to regulatory approval. Circulation 109 (2004), 3068–3072.
    • (2004) Circulation , vol.109 , pp. 3068-3072
    • Kaplan, A.V.1    Baim, D.S.2    Smith, J.J.3
  • 41
    • 79956305129 scopus 로고    scopus 로고
    • Europeans are left to their own devices
    • 41 Cohen, D., Billingsley, M., Europeans are left to their own devices. BMJ, 342, 2011, d2952.
    • (2011) BMJ , vol.342 , pp. d2952
    • Cohen, D.1    Billingsley, M.2
  • 42
    • 84868013763 scopus 로고    scopus 로고
    • The EU's system for regulating medical devices: now is the time for radical change
    • 42 McCulloch, P., The EU's system for regulating medical devices: now is the time for radical change. BMJ, 345, 2012, e7126.
    • (2012) BMJ , vol.345 , pp. e7126
    • McCulloch, P.1
  • 43
    • 84872031118 scopus 로고    scopus 로고
    • The truth behind “made in Europe” labels on medical devices
    • 43 Cohen, D., The truth behind “made in Europe” labels on medical devices. BMJ, 345, 2012, e7193.
    • (2012) BMJ , vol.345 , pp. e7193
    • Cohen, D.1
  • 44
    • 84886936427 scopus 로고    scopus 로고
    • Devices and desires: industry fights toughening of medical device regulation in Europe
    • 44 Cohen, D., Devices and desires: industry fights toughening of medical device regulation in Europe. BMJ, 347, 2013, f6204.
    • (2013) BMJ , vol.347 , pp. f6204
    • Cohen, D.1
  • 45
    • 84864422985 scopus 로고    scopus 로고
    • How does medical device approval regulation perform in the United States and the European Union? A systematic review
    • 45 Kramer, D.B., Xu, S., Kesselheim, A.S., How does medical device approval regulation perform in the United States and the European Union? A systematic review. PLos Med, 9, 2012, e1001276.
    • (2012) PLos Med , vol.9 , pp. e1001276
    • Kramer, D.B.1    Xu, S.2    Kesselheim, A.S.3
  • 46
    • 84857828102 scopus 로고    scopus 로고
    • Postmarketing surveillance of medical devices—filling in the gaps
    • 46 Resnic, F.S., Normand, S.L.T., Postmarketing surveillance of medical devices—filling in the gaps. N Engl J Med 366 (2012), 875–877.
    • (2012) N Engl J Med , vol.366 , pp. 875-877
    • Resnic, F.S.1    Normand, S.L.T.2
  • 47
    • 84864669609 scopus 로고    scopus 로고
    • Patient access to medical devices—a comparison of U.S. and European review processes
    • 47 Basu, S., Hassenplug, J.C., Patient access to medical devices—a comparison of U.S. and European review processes. N Engl J Med 367 (2012), 485–488.
    • (2012) N Engl J Med , vol.367 , pp. 485-488
    • Basu, S.1    Hassenplug, J.C.2
  • 48
    • 84901723222 scopus 로고    scopus 로고
    • Only 3 in 20 new drugs approved in Germany in 2011 were an improvement, report says
    • 48 Stafford, N., Only 3 in 20 new drugs approved in Germany in 2011 were an improvement, report says. BMJ, 348, 2014, g2657.
    • (2014) BMJ , vol.348 , pp. g2657
    • Stafford, N.1
  • 50
    • 78650149063 scopus 로고    scopus 로고
    • Medical devices and the approval processes: United States vs. France
    • 50 Braillon, A., Medical devices and the approval processes: United States vs. France. Arch Intern Med 170 (2010), 2040–2041.
    • (2010) Arch Intern Med , vol.170 , pp. 2040-2041
    • Braillon, A.1
  • 51
    • 84879355922 scopus 로고    scopus 로고
    • The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?
    • 51 Fargen, K.M., Frei, D., Fiorella, D., et al. The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation?. J Neurointerv Surg 5 (2013), 269–275.
    • (2013) J Neurointerv Surg , vol.5 , pp. 269-275
    • Fargen, K.M.1    Frei, D.2    Fiorella, D.3
  • 52
    • 78650895852 scopus 로고    scopus 로고
    • Review of the processes for FDA oversight of drugs, medical devices and combination products
    • 52 Sweet, B.V., Schwemm, A.K., Parsons, D.M., Review of the processes for FDA oversight of drugs, medical devices and combination products. J Manage Care Pharm 17 (2011), 40–50.
    • (2011) J Manage Care Pharm , vol.17 , pp. 40-50
    • Sweet, B.V.1    Schwemm, A.K.2    Parsons, D.M.3
  • 53
    • 79955726540 scopus 로고    scopus 로고
    • Medical device recalls and the FDA approval process
    • 53 Zuckerman, D.M., Brown, P., Nissen, S.E., Medical device recalls and the FDA approval process. Arch Intern Med 171 (2011), 1006–1011.
    • (2011) Arch Intern Med , vol.171 , pp. 1006-1011
    • Zuckerman, D.M.1    Brown, P.2    Nissen, S.E.3
  • 54
    • 85002531681 scopus 로고    scopus 로고
    • Drug Administration. Understanding Barriers to Medical Device Quality. Available at: Accessed June 3
    • 54 U.S. Food and Drug Administration. Understanding Barriers to Medical Device Quality. Available at: http://google2.fda.gov/search?q=understanding+barriers+to+medical+device+quality&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*. Accessed June 3, 2016.
    • (2016)
    • Food, U.S.1
  • 55
    • 85002815363 scopus 로고    scopus 로고
    • H.R. 3095 Safe Medical Devices Act of 1990. Available at: https://www.congress.gov/bill/101st-congress/house-bill/3095 Accessed June 3
    • 55 H.R. 3095 Safe Medical Devices Act of 1990. Congress.gov Available at: https://www.congress.gov/bill/101st-congress/house-bill/3095. Accessed June 3, 2016.
    • (2016)
  • 56
    • 84872082045 scopus 로고    scopus 로고
    • The 501(k) ancestry of a metal-on-metal hip implant
    • 56 Ardaugh, B.M., Graves, S.E., Redberg, R.F., The 501(k) ancestry of a metal-on-metal hip implant. N Engl J Med 368 (2013), 97–100.
    • (2013) N Engl J Med , vol.368 , pp. 97-100
    • Ardaugh, B.M.1    Graves, S.E.2    Redberg, R.F.3
  • 57
    • 85002649380 scopus 로고    scopus 로고
    • Drug Administration. How to Find and Effectively Use Predicate Devices. Available at: Accessed June 3
    • 57 U.S. Food and Drug Administration. How to Find and Effectively Use Predicate Devices. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/ucm134571.htm. Accessed June 3, 2016.
    • (2016)
    • Food, U.S.1
  • 58
    • 84883346979 scopus 로고    scopus 로고
    • Unsafe and Ineffective Devices Approved in the EU That Were Not Approved in the US
    • U.S. FDA Silver Spring, MD Available at: Accessed June 3, 2016
    • 58 U.S. Food and Drug Administration. Unsafe and Ineffective Devices Approved in the EU That Were Not Approved in the US. 2012, U.S. FDA, Silver Spring, MD Available at: http://www.elsevierbi.com/∼/media/Supporting%20Documents/The%20Gray%20Sheet/38/20/FDA_EU_Devices_Report.pdf Accessed June 3, 2016.
    • (2012)
  • 59
    • 80155187291 scopus 로고    scopus 로고
    • Le Dispositif Médical
    • Presses Universitaires de France Paris, France
    • 59 Audry, A., Ghislain, J.C., Le Dispositif Médical. 2009, Presses Universitaires de France, Paris, France, 55–57.
    • (2009) , pp. 55-57
    • Audry, A.1    Ghislain, J.C.2
  • 60
    • 80052863459 scopus 로고    scopus 로고
    • Medical devices–balancing regulation and innovation
    • 60 Curfman, G.D., Redberg, R.F., Medical devices–balancing regulation and innovation. N Engl J Med 365 (2011), 975–977.
    • (2011) N Engl J Med , vol.365 , pp. 975-977
    • Curfman, G.D.1    Redberg, R.F.2
  • 61
    • 85003021628 scopus 로고    scopus 로고
    • Drug Administration. Recall, Market Withdrawals and Safety Alerts. Available at: Accessed June 3
    • 61 U.S. Food and Drug Administration. Recall, Market Withdrawals and Safety Alerts. Available at: http://www.fda.gov/Safety/Recalls/default.htm. Accessed June 3, 2016.
    • (2016)
    • Food, U.S.1
  • 62
    • 84864417983 scopus 로고    scopus 로고
    • The epidemiology of drug recalls in the United States
    • 62 Wang, B., Gagne, J.J., Choudry, N.K., The epidemiology of drug recalls in the United States. Arch Intern Med 172 (2012), 1109–1110.
    • (2012) Arch Intern Med , vol.172 , pp. 1109-1110
    • Wang, B.1    Gagne, J.J.2    Choudry, N.K.3
  • 63
    • 85002783497 scopus 로고    scopus 로고
    • Drug Administration. February 25, 2010: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA. Available at: Accessed June 19
    • 63 U.S. Food and Drug Administration. February 25, 2010: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA. Available at: http://www.fda.gov/ICECI/CriminalInvestigations/ucm272226.htm. Accessed June 19, 2016.
    • (2016)
    • Food, U.S.1
  • 64
    • 85002891777 scopus 로고    scopus 로고
    • Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012. Available at: Accessed June 3
    • 64 Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF. Accessed June 3, 2016.
    • (2016)
  • 65
    • 85002681294 scopus 로고    scopus 로고
    • European Commission. Medicinal Products for Human Use: The EU Pharmacovigilance System. Available at: Accessed June 3
    • 65 European Commission. Medicinal Products for Human Use: The EU Pharmacovigilance System. Available at: http://ec.europa.eu/health/human-use/pharmacovigilance/index_en.htm. Accessed June 3, 2016.
    • (2016)
  • 66
    • 79551575056 scopus 로고    scopus 로고
    • Trial watch: phase II and submission failures 2007-2010
    • 66 Arrowsmith, J., Trial watch: phase II and submission failures 2007-2010. Nat Rev Drug Discov, 10, 2011, 87.
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 87
    • Arrowsmith, J.1
  • 67
    • 4344645978 scopus 로고    scopus 로고
    • Can the pharmaceutical industry reduce attrition rates?
    • 67 Kola, I., Landis, J., Can the pharmaceutical industry reduce attrition rates?. Nat Rev Drug Discov 3 (2004), 711–715.
    • (2004) Nat Rev Drug Discov , vol.3 , pp. 711-715
    • Kola, I.1    Landis, J.2
  • 68
    • 53249132632 scopus 로고    scopus 로고
    • Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
    • 68 Eichler, H.G., Pgnatti, F., Flamion, B., Leufkens, H., Breckenridge, A., Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 7 (2008), 818–826.
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 818-826
    • Eichler, H.G.1    Pgnatti, F.2    Flamion, B.3    Leufkens, H.4    Breckenridge, A.5
  • 69
    • 34247463760 scopus 로고    scopus 로고
    • Paying for drug approval—who's using whom?
    • 69 Ajorn, J., Paying for drug approval—who's using whom?. N Engl J Med 356 (2007), 1697–1700.
    • (2007) N Engl J Med , vol.356 , pp. 1697-1700
    • Ajorn, J.1
  • 70
    • 84943661661 scopus 로고    scopus 로고
    • Approvals of drugs with uncertain benefit-risk profiles in Europe
    • 70 Banzi, R., Gerardi, C., Bertele, V., Garattini, S., Approvals of drugs with uncertain benefit-risk profiles in Europe. Eur J Int Med 26 (2015), 572–584.
    • (2015) Eur J Int Med , vol.26 , pp. 572-584
    • Banzi, R.1    Gerardi, C.2    Bertele, V.3    Garattini, S.4
  • 71
    • 0035174918 scopus 로고    scopus 로고
    • Post marketing surveillance and vigilance for medical devices: the European approach
    • 71 Randall, H., Post marketing surveillance and vigilance for medical devices: the European approach. Drug Safety 24 (2001), 869–872.
    • (2001) Drug Safety , vol.24 , pp. 869-872
    • Randall, H.1
  • 72
    • 84946846218 scopus 로고    scopus 로고
    • The Poly Implant Prosthèse breast prosthesis scandal: embodied risk and social suffering
    • 72 Greco, C., The Poly Implant Prosthèse breast prosthesis scandal: embodied risk and social suffering. Soc Sci Med 147 (2014), 150–157.
    • (2014) Soc Sci Med , vol.147 , pp. 150-157
    • Greco, C.1
  • 73
    • 84860556556 scopus 로고    scopus 로고
    • The saga of Poly Implant Prosthèse breast implants
    • 73 Heneghan, C., The saga of Poly Implant Prosthèse breast implants. BMJ, 344, 2012, e306.
    • (2012) BMJ , vol.344 , pp. e306
    • Heneghan, C.1
  • 74
    • 84864429441 scopus 로고    scopus 로고
    • Medical device regulation: time to improve performance
    • 74 Dhruva, S.S., Redberg, R.F., Medical device regulation: time to improve performance. PLoS Med, 9, 2012, e1001277.
    • (2012) PLoS Med , vol.9 , pp. e1001277
    • Dhruva, S.S.1    Redberg, R.F.2
  • 75
    • 84864479895 scopus 로고    scopus 로고
    • In search of the shocking truth
    • 75 Kaszala, K., Ellenbogen, K.A., In search of the shocking truth. Heart Rhythm 9 (2012), 1236–1238.
    • (2012) Heart Rhythm , vol.9 , pp. 1236-1238
    • Kaszala, K.1    Ellenbogen, K.A.2
  • 76
    • 84864485036 scopus 로고    scopus 로고
    • Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families
    • 76 Liu, J., Brumber, G., Rattan, R., Jain, S., Saba, S., Class I recall of defibrillator leads: a comparison of the Sprint Fidelis and Riata families. Heart Rhythm 9 (2012), 1251–1255.
    • (2012) Heart Rhythm , vol.9 , pp. 1251-1255
    • Liu, J.1    Brumber, G.2    Rattan, R.3    Jain, S.4    Saba, S.5
  • 77
    • 84864423015 scopus 로고    scopus 로고
    • Deaths caused by failure of Riata and Riata ST implantable cardioverter-defibrillator leads
    • 77 Hauser, R.G., Abdelhadi, R., McGriff, D., Retel, L.K., Deaths caused by failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm 9 (2012), 1227–1235.
    • (2012) Heart Rhythm , vol.9 , pp. 1227-1235
    • Hauser, R.G.1    Abdelhadi, R.2    McGriff, D.3    Retel, L.K.4
  • 78
    • 84857886806 scopus 로고    scopus 로고
    • Here we go again—another failure of postmarketing device surveillance
    • 78 Hause, R.G., Here we go again—another failure of postmarketing device surveillance. N Engl J Med 366 (2012), 873–875.
    • (2012) N Engl J Med , vol.366 , pp. 873-875
    • Hause, R.G.1
  • 79
    • 85002711114 scopus 로고    scopus 로고
    • European Commission. Directive 85/374/EC: Liability for Defective Products. Available at: Accessed June 3
    • 79 European Commission. Directive 85/374/EC: Liability for Defective Products. Available at: http://www.seio.gov.rs/upload/documents/skrining/eksplanatorni/prezentacije/pg28/28_3.pdf. Accessed June 3, 2016.
    • (2016)
  • 80
    • 84857863524 scopus 로고    scopus 로고
    • Medical-device recalls in the UK and the device regulation process: retrospective review of safety notices and recalls
    • 80 Heneghan, C., Thompson, M., Billingsley, M., Cohen, D., Medical-device recalls in the UK and the device regulation process: retrospective review of safety notices and recalls. BMJ Open, 1, 2011, e000155.
    • (2011) BMJ Open , vol.1 , pp. e000155
    • Heneghan, C.1    Thompson, M.2    Billingsley, M.3    Cohen, D.4
  • 81
    • 85002792540 scopus 로고    scopus 로고
    • The U.S. Approval Process for Medical Devices: Legislative Issues and Comparison With the Drug Model. Order Code RL 32826. Congressional Research Service (CRS) Report for Congress. March 23, 2005. University of Maryland School of Law. Available at: Accessed December 1
    • 81 Schoonmaker M. The U.S. Approval Process for Medical Devices: Legislative Issues and Comparison With the Drug Model. Order Code RL 32826. Congressional Research Service (CRS) Report for Congress. March 23, 2005. University of Maryland School of Law. Available at: http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3282603232005.pdf. Accessed December 1, 2010.
    • (2010)
    • Schoonmaker, M.1
  • 82
    • 84900867105 scopus 로고    scopus 로고
    • Assessment of cardiovascular and noncardiovascular medical device recalls
    • 82 Somberg, J.C., McEwen, P., Molnar, J., Assessment of cardiovascular and noncardiovascular medical device recalls. Am J Cardiol 113 (2014), 1899–1903.
    • (2014) Am J Cardiol , vol.113 , pp. 1899-1903
    • Somberg, J.C.1    McEwen, P.2    Molnar, J.3
  • 83
    • 84925539785 scopus 로고    scopus 로고
    • The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges
    • 83 Dal Pan, G.J., Arlett, P.R., The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges. Drug Saf 38 (2015), 13–15.
    • (2015) Drug Saf , vol.38 , pp. 13-15
    • Dal Pan, G.J.1    Arlett, P.R.2
  • 84
    • 85002584847 scopus 로고    scopus 로고
    • European Commission. 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. Available at: Accessed June 3
    • 84 European Commission. 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. Available at: http://data.consilium.europa.eu/doc/document/ST-9769-2015-INIT/en/pdf. Accessed June 3, 2016.
    • (2016)


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.