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Volumn 353, Issue , 2016, Pages

Regulatory approval of new medical devices: Cross sectional study

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CROSS-SECTIONAL STUDY; DATA BASE; DEVICE APPROVAL; FOOD AND DRUG ADMINISTRATION; INFORMATION RETRIEVAL; MEDICAL DEVICE; MEDLINE; PRIORITY JOURNAL; CLINICAL STUDY; DEVICES; HEALTH CARE COST; HUMAN; LEGISLATION AND JURISPRUDENCE; ORGANIZATION; PROSTHESES AND ORTHOSES; STANDARDS;

EID: 84969849830     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.i2587     Document Type: Article
Times cited : (45)

References (22)
  • 1
    • 0028012426 scopus 로고
    • Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland
    • Steiner CA, Bass EB, Talamini MA, Pitt HA, Steinberg EP. Surgical rates and operative mortality for open and laparoscopic cholecystectomy in Maryland. N Engl J Med 1994;330:403-8. doi:10.1056/NEJM199402103300607.
    • (1994) N Engl J Med , vol.330 , pp. 403-408
    • Steiner, C.A.1    Bass, E.B.2    Talamini, M.A.3    Pitt, H.A.4    Steinberg, E.P.5
  • 2
    • 70349288302 scopus 로고    scopus 로고
    • Balliol Collaboration. Evaluation and stages of surgical innovations
    • Barkun JS, Aronson JK, Feldman LS, et al. Balliol Collaboration. Evaluation and stages of surgical innovations. Lancet 2009;374:1089-96. doi:10.1016/S0140-6736(09)61083-7.
    • (2009) Lancet , vol.374 , pp. 1089-1096
    • Barkun, J.S.1    Aronson, J.K.2    Feldman, L.S.3
  • 3
    • 78650029986 scopus 로고    scopus 로고
    • Translational research: Understanding the continuumfrom bench to bedside
    • Drolet BC, Lorenzi NM. Translational research: understanding the continuum from bench to bedside. Transl Res 2011;157:1-5. doi:10.1016/j.trsl.2010.10.002.
    • (2011) Transl Res , vol.157 , pp. 1-5
    • Drolet, B.C.1    Lorenzi, N.M.2
  • 4
    • 79956296633 scopus 로고    scopus 로고
    • Medical device recalls and transparency in the UK
    • Thompson M, Heneghan C, Billingsley M, Cohen D. Medical device recalls and transparency in the UK. BMJ 2011;342:d2973. doi:10.1136/bmj.d2973.
    • (2011) BMJ , vol.342 , pp. d2973
    • Thompson, M.1    Heneghan, C.2    Billingsley, M.3    Cohen, D.4
  • 5
    • 84925282784 scopus 로고    scopus 로고
    • Lack of publicly. Available scientific evidence on the safety and effectiveness of implanted medical devices
    • Zuckerman D, Brown P, Das A. Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med 2014;174:1781-7. doi:10.1001/ jamainternmed.2014.4193.
    • (2014) JAMA Intern Med , vol.174 , pp. 17817
    • Zuckerman, D.1    Brown, P.2    Das, A.3
  • 6
    • 79955726540 scopus 로고    scopus 로고
    • Medical device recalls and the FDA approval process
    • Zuckerman DM, Brown P, Nissen SE. Medical device recalls and the FDA approval process. Arch Intern Med 2011;171:1006-11. doi:10.1001/archinternmed.2011.30.
    • (2011) Arch Intern Med , vol.171 , pp. 1006-1011
    • Zuckerman, D.M.1    Brown, P.2    Nissen, S.E.3
  • 7
    • 51149116101 scopus 로고    scopus 로고
    • Medicine.Life cycle of translational research for medical interventions
    • Contopoulos-Ioannidis DG, Alexiou GA, Gouvias TC, Ioannidis JP. Medicine. Life cycle of translational research for medical interventions. Science 2008;321:1298-9. doi:10.1126/ science.1160622.
    • (2008) Science , vol.321 , pp. 1298-1299
    • Contopoulos-Ioannidis, D.G.1    Alexiou, G.A.2    Gouvias, T.C.3    Ioannidis, J.P.4
  • 8
    • 0037447488 scopus 로고    scopus 로고
    • Translation of highly promising basic science research into clinical applications
    • Contopoulos-Ioannidis DG, Ntzani E, Ioannidis JP. Translation of highly promising basic science research into clinical applications. Am J Med 2003;114:477-84. doi:10.1016/S0002-9343(03)00013-5.
    • (2003) Am J Med , vol.114 , pp. 477-484
    • Contopoulos-Ioannidis, D.G.1    Ntzani, E.2    Ioannidis, J.P.3
  • 9
    • 84953238080 scopus 로고    scopus 로고
    • Making the leap: The translation of innovative surgical devices from the laboratory to the operating room
    • Marcus HJ, Payne CJ, Hughes-Hallett A, et al. Making the leap: The translation of innovative surgical devices from the laboratory to the operating room. Ann Surg 2015. doi:10.1097/SLA.0000000000001532.
    • (2015) Ann Surg
    • Marcus, H.J.1    Payne, C.J.2    Hughes-Hallett, A.3
  • 10
    • 84875792798 scopus 로고    scopus 로고
    • Robotic surgery: Revisiting no innovation without evaluation
    • Paul S, McCulloch P, Sedrakyan A. Robotic surgery: revisiting no innovation without evaluation. BMJ 2013;346:f1573.
    • (2013) BMJ , vol.346 , pp. f1573
    • Paul, S.1    McCulloch, P.2    Sedrakyan, A.3
  • 11
    • 84859007825 scopus 로고    scopus 로고
    • The regulation of medical devices
    • Wilmshurst P. The regulation of medical devices. BMJ 2011;342:d2822. doi:10.1136/bmj.d2822.
    • (2011) BMJ , vol.342 , pp. d2822
    • Wilmshurst, P.1
  • 12
    • 84988892551 scopus 로고    scopus 로고
    • Appraisal of evidence base for introduction of new implants in hip and knee replacement: A systematic review of five widely used device technologies
    • Nieuwenhuijse MJ, Nelissen RG, Schoones JW, Sedrakyan A. Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies. BMJ 2014;349:g5133. doi:10.1136/bmj.g5133.
    • (2014) BMJ , vol.349 , pp. g5133
    • Nieuwenhuijse, M.J.1    Nelissen, R.G.2    Schoones, J.W.3    Sedrakyan, A.4
  • 13
    • 84988813583 scopus 로고    scopus 로고
    • Regulating incremental innovation in medical devices
    • Kesselheim AS, Rajan PV. Regulating incremental innovation in medical devices. BMJ 2014;349:g5303. doi:10.1136/bmj.g5303.
    • (2014) BMJ , vol.349 , pp. g5303
    • Kesselheim, A.S.1    Rajan, P.V.2
  • 14
    • 84882263837 scopus 로고    scopus 로고
    • IDEAL framework for surgical innovation 3: Randomised controlled trials in the assessment stage and evaluations in the long term study stage
    • Cook JA, McCulloch P, Blazeby JM, et al. IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage. BMJ 2013;346:f2820
    • (2013) BMJ , vol.346 , pp. f2820
    • Cook, J.A.1    McCulloch, P.2    Blazeby, J.M.3
  • 15
    • 84882271390 scopus 로고    scopus 로고
    • IDEAL framework for surgical innovation 2: Observational studies in the exploration and assessment stages
    • Ergina PL, Barkun JS, McCulloch P, et al. IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages. BMJ 2013:346:f3011.
    • (2013) BMJ , vol.346 , pp. f3011
    • Ergina, P.L.1    Barkun, J.S.2    McCulloch, P.3
  • 16
    • 84882253558 scopus 로고    scopus 로고
    • IDEAL framework for surgical innovation 1: The idea and development stages
    • McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: the idea and development stages. BMJ 2013:346:f3012.
    • (2013) BMJ , vol.346 , pp. f3012
    • McCulloch, P.1    Cook, J.A.2    Altman, D.G.3
  • 17
    • 70349280608 scopus 로고    scopus 로고
    • Balliol Collaboration. No surgical innovation without evaluation: The IDEAL recommendations
    • McCulloch P, Altman DG, Campbell WB, et al. Balliol Collaboration. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105-12. doi:10.1016/S0140-6736(09)61116-8.
    • (2009) Lancet , vol.374 , pp. 1105-1112
    • McCulloch, P.1    Altman, D.G.2    Campbell, W.B.3
  • 18
    • 70349294326 scopus 로고    scopus 로고
    • Balliol Collaboration. Challenges in evaluating surgical innovation
    • Ergina PL, Cook JA, Blazeby JM, et al. Balliol Collaboration. Challenges in evaluating surgical innovation. Lancet 2009;374:1097-104. doi:10.1016/S0140-6736(09)61086-2.
    • (2009) Lancet , vol.374 , pp. 1097-1104
    • Ergina, P.L.1    Cook, J.A.2    Blazeby, J.M.3
  • 19
    • 84867800386 scopus 로고    scopus 로고
    • Postmarket surveillance for medical devices: America's new strategy
    • Res C, ed.
    • Normand SLT, Hatfield L, Drozda J, et al. In: Res C, ed. Postmarket surveillance for medical devices: America's new strategy. BMJ 2012:345.
    • (2012) BMJ , vol.345
    • Normand, S.L.T.1    Hatfield, L.2    Drozda, J.3
  • 20
    • 84870705229 scopus 로고    scopus 로고
    • Creating a space for innovative device development
    • 163fs43
    • McMurry-Heath M, Hamburg MA. Creating a space for innovative device development. Sci Transl Med 2012;4:163fs43. doi:10.1126/ scitranslmed.3005269.
    • (2012) Sci Transl Med , vol.4
    • McMurry-Heath, M.1    Hamburg, M.A.2
  • 21
    • 84936849945 scopus 로고    scopus 로고
    • Selective reporting in trials of high risk cardiovascular devices: Cross sectional comparison between premarket approval summaries and published reports
    • Chang L, Dhruva SS, Chu J, Bero LA, Redberg RF. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports. BMJ 2015;350:h2613. doi:10.1136/bmj.h2613.
    • (2015) BMJ , vol.350 , pp. h2613
    • Chang, L.1    Dhruva, S.S.2    Chu, J.3    Bero, L.A.4    Redberg, R.F.5
  • 22
    • 84939133213 scopus 로고    scopus 로고
    • Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011
    • Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of clinical studies conducted over the total product life cycle of high-risk therapeutic medical devices receiving FDA premarket approval in 2010 and 2011. JAMA 2015;314:604-12. doi:10.1001/jama.2015.8761.
    • JAMA , vol.2015 , Issue.314 , pp. 604-612
    • Rathi, V.K.1    Krumholz, H.M.2    Masoudi, F.A.3    Ross, J.S.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.