Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

References

• Ramsay CR, Grant AM, Wallace SA, et al. Statistical assessment of the learning curves of health technologies. Health Technol Assess 2001;5(12):1-79
   PubMedGoogle Scholar
• Altenstetter C. EU and member state medical devices regulation. Int J Technol Assess Health Care 2003;19(1):228-48
   PubMedGoogle Scholar
• Sorenson C, Tarricone R, Siebert M, Drummond M. Applying health economics for policy decision making: do devices differ from drugs? Europace 2011;13(Suppl 2):ii54-8
   PubMedGoogle Scholar
• Drummond M, Griffin A, Tarricone R. Economic evaluation for devices and drugs – same or different? Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 2009;12(4):402-4
   PubMed Web of Science ®Google Scholar
• WHO. Guiding principles and Essential features of a Regulatory Program for Medical Devices Publication, Geneva. 2001
   Google Scholar
• Jefferys DB. The regulation of medical devices and the role of the Medical Devices Agency. Br J Clin Pharmacol 2001;52(3):229-35
   PubMedGoogle Scholar
• Global Harmonization Task Force. Principles of Conformity Assessment for Medical Devices. Available from: http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-conformity-assessment-medical-devices-121102.pdf 2012
   Google Scholar
• International Medical Device Regulators Forum. Available from: http://www.imdrf.org/
   Google Scholar
• MedtecHTA. Available from: www.medtechta.eu
   Google Scholar
• Faulkner A, Kent J. Innovation and regulation in human implant technologies: developing comparative approaches. Social Science and Medicine 2001;53(7):895-913
   PubMedGoogle Scholar
• Bauman J. The “Deja Vu Effect:” Evaluation of United States medical device legislation, regulation, and the Food and Drug Administration’s contentious 510(k) program. Food Drug Law J 2012;67(3):337-61
   PubMedGoogle Scholar
• Buch B. FDA medical device approval: things you didn’t learn in medical school or residency. Am J Orthop 2007;36(8):407-12
   PubMedGoogle Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Pietzsch JB, Shluzas LA, Pate-Cornell ME, et al. Stage-gate process for the development of medical devices. J Med Devices, Transactions of the ASME 2009;3:2
   Google Scholar
• Pietzsch JB, Zanchi MG, Linehan JH. Medical Device Innovators and the 510(k) Regulatory Pathway: Implications of a Survey-Based Assessment of Industry Experience. J Med Devices, Transactions of the ASME 2012;6:2
   Google Scholar
• Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med 2011;171(11):1006-11
   PubMedGoogle Scholar
• Basu S, Hassenplug JC. Patient access to medical devices – a comparison of U.S. and European review processes. N Engl J Med 2012;367(6):485-8
   PubMed Web of Science ®Google Scholar
• Fraser AG, Krucoff MW, Brindis RG, et al. Commentary: international collaboration needed on device clinical standards. Bmj 2011;342:d2952
   PubMedGoogle Scholar
• Kramer DB, Xu S, Kesselheim AS. How does medical device regulation perform in the United States and the European union? A systematic review. PLoS Med 2012;9(7):e1001276
   PubMed Web of Science ®Google Scholar
• McHugh M, McCaffery F, Casey V. Changes to the international regulatory environment. J Med Devices, Transactions of the ASME 2012;6:2
   Google Scholar
• Vinck I, Hulstaert F, Van Brabandt H, et al. Market introduction of innovative high risk medical devices: towards a recast of the directive concerning medical devices. Eur J Health Law 2011;18(5):477-89
   PubMedGoogle Scholar
• Pooja G, Manthan D, Puralea C, Nayanabhirama U. Medical device vigilance systems: India, US, UK, and Australia. Medical devices: Evidence and Research 2010;3:67-79
   Google Scholar
• Liu GG, Fukuda T, Lee CE, et al. Evidence-based decision-making on medical technologies in China, Japan, and Singapore. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research 2009;12(Suppl 3):S12-17
   Google Scholar
• Hattangadi JA, O’Reilly JT, Recht A. US Food and Drug Administration regulation of medical devices and radiation oncology: can reform improve safety? Journal of Oncology Practice 2012;8(1):53-6
   PubMedGoogle Scholar
• Muni NI, Gross TP, Boam AB, et al. Challenges in regulating breakthrough medical devices. Food Drug Law J 2005;60(2):137-42 +ii
   PubMedGoogle Scholar
• Basile EM, Lorell BH. The food and drug administration’s regulation of risk disclosure for implantable cardioverter defibrillators: has technology outpaced the agency’s regulatory framework? Food Drug Law J 2006;61(2):251-72
   PubMedGoogle Scholar
• Kaplan AV, Williams DO. Medical device regulatory landscape: the imperative of finding balance. Circ 2012;5(1):2-5
   PubMedGoogle Scholar
• Fraser AG, Daubert JC, Van de Werf F, et al. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology. Eur Heart J 2011;32(13):1673-86
   PubMedGoogle Scholar
• Bleicher EW. Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context. Food Drug Law J 2009;64(3):531-64
   PubMedGoogle Scholar
• Cohen D. Faulty hip implant shows up failings of EU regulation. Bmj 2012;345:e7163
   PubMed Web of Science ®Google Scholar
• Curfman GD, Redberg RF. Medical devices – balancing regulation and innovation. N Engl J Med 2011;365(11):975-7
   PubMed Web of Science ®Google Scholar
• Rising JP, Reynolds IS, Sedrakyan A. Delays and difficulties in assessing metal-on-metal hip implants. N Engl J Med 2012;367(1):e1
   PubMedGoogle Scholar
• Gross TP, Crowley J. Unique device identification in the service of public health. N Engl J Med 2012;367(17):1583-5
   PubMedGoogle Scholar
• Hauser RG. Here we go again – failure of postmarketing device surveillance. N Engl J Med 2012;366(10):873-5
   PubMed Web of Science ®Google Scholar
• Resnic FS, Normand SL. Postmarketing surveillance of medical devices – filling in the gaps. N Engl J Med 2012;366(10):875-7
   PubMed Web of Science ®Google Scholar
• Heneghan C, Thompson M. Rethinking medical device regulation. J R Soc Med 2012;105(5):186-8
   PubMedGoogle Scholar
• European Commission. Restoring confidence in medical devices. Action Plan after the PIP scandal tightened control in Europe. Available from: http://europa.eu/rapid/press-release_IP-14-699_en.htm 2014
   Google Scholar
• Challoner DR, Vodra WW. Medical devices and health – creating a new regulatory framework for moderate-risk devices. N Engl J Med 2011;365(11):977-9
   PubMedGoogle Scholar
• Tsoi B, Masucci L, Campbell K, et al. Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences. Expert Rev Pharmacoecon Outcomes Res 2013;13(4):497-511
   PubMed Web of Science ®Google Scholar
• Cohen D, Billingsley M. Europeans are left to their own devices. Bmj 2011;342:d2748
   PubMed Web of Science ®Google Scholar
• WHO. Medical Device Regulation. Global overview and guiding principles. Publication. WHO; (Geneva: 2003
   Google Scholar
• Cohen MR. Why error reporting systems should be voluntary. Bmj 2000;320(7237):728-9
   PubMed Web of Science ®Google Scholar
• Kaushik A, Saini KS, Singh BK, Singh SP. Regulation of medical device adverse reporting – To Whom, when and how. Pharma Times 2011;43(2):18-21
   Google Scholar
• McGee RG, Webster AC, Rogerson TE, Craig JC. Medical device regulation in Australia: safe and effective? Med J Aust 2012;196(4):256-60
   PubMed Web of Science ®Google Scholar
• Thompson M, Heneghan C, Billingsley M, Cohen D. Medical device recalls and transparency in the UK. Bmj 2011;342:d2973
   PubMed Web of Science ®Google Scholar
• Gross TP, Crowley J. Unique device identification and public health. N Engl J Med 2013;368(7):683-4
   PubMedGoogle Scholar
• MHRA. New. Legislation on Medical Devices. Available from: http://www.mhra.gov.uk/Howweregulate/Devices/Legislation/NewLegislationonMedicalDevices/index.htm 2012
   Google Scholar
• Tommaso CL, Bolman RM 3rd, Feldman T, et al. Multisociety (AATS, ACCF, SCAI, and STS) expert consensus statement: operator and institutional requirements for transcatheter valve repair and replacement, part 1: transcatheter aortic valve replacement. J Am Coll Cardiol 2012;59(22):2028-42
   PubMedGoogle Scholar
• Henshall C, Mardhani-Bayne L, Fronsdal KB, Klemp M. Interactions between health technology assessment, coverage, and regulatory processes: emerging issues, goals, and opportunities. Int J Technol Assess Health Care 2011;27(3):253-60
   PubMedGoogle Scholar