美国医疗器械上市前通告制度的演变及启示
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摘要
美国是最早立法管理医疗器械的国家,其监管模式的科学性和系统性已被世界上大多数国家和地区认可。本文以美国上市前通告制度为切入点,介绍各项法规的制修订对上市前通告制度带来的变革,以及种种变革对企业注册申请情况的影响,希望能够为我国医疗器械的监管提供启示。
USA is the earliest country to legislate laws and regulations about medical device administration,whose scientific and systematic regulatory model has already been recognized by most countries and regions in the world. Based on the USA medical device premarket notification system, this article introduces the changes brought about by the revision of various laws and regulations to the premarket notification system, and the impact of various changes on the application for enterprise registration in order to provide enlightenment for the supervision of medical devices in China.
USA is the earliest country to legislate laws and regulations about medical device administration,whose scientific and systematic regulatory model has already been recognized by most countries and regions in the world. Based on the USA medical device premarket notification system, this article introduces the changes brought about by the revision of various laws and regulations to the premarket notification system, and the impact of various changes on the application for enterprise registration in order to provide enlightenment for the supervision of medical devices in China.
引文
[1]陈以桢,高惠君.美国、欧盟医疗器械法规概况及与我国法规的对比[J].中国医疗器械信息,2008,32(3):218-226.
[2]US Food and Drug Administration.FDA and Industry Procedures for Section 513(g)Requests for Information under the Federal Food,Drug,and Cosmetic Act[EB/OL].(2012-04-06)[2019-01-02].http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209841.htm.
[3]US Food and Drug Administration.User Fees for 513(g)Requests for Information Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2017-10-2)[2019-01-02].http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209852.htm.
[4]卢爱丽,薛玲,孙京昇.对美国医疗器械监管的研究[J].首都医药,2008,(6):4-6.
[5]屈宝刚.美国医疗器械法规介绍[J].中国医疗器械信息,2005,(1):29-30.
[6]沈翀.美国FDA医疗器械和放射健康中心(CDRH)医疗器械监管模式概述[J].中国医疗设备,2010,25(3):129-131.
[7]张冬娟.美国和欧盟的医疗器械监管[J].中国信息界(e医疗),2012,(7):30-31.
[8]常永亨.美国对高风险医疗器械的审批[J].中国医疗器械杂志,2013,37(2):132-136.
[9]岳伟.我国医疗器械注册制度与美国510K注册的比较[J].中国医疗器械杂志,2009,3(1):51-58.
[10]王兰明,王宿.美国、欧盟医疗器械上市许可管理制度及其启示[J].中国药业,2012,21(24):1-5.
[11]US Food and Drug Administration.The 510(k)Program:Evaluating Substantial Equivalence in Premarket Notifications[510(k)][EB/OL].(2014-07-28)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.
[12]张世庆,邓洁,章金刚.美国医疗器械监管模式概述[J].中国医疗器械信息,2009,15(10):62-66+82.
[13]US Food and Drug Administration.De Novo Classification Process(Evaluation of Automatic Class III Designation)[EB/OL].(2017-10-30)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080197.
[14]US Food and Drug Administration.Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions[EB/OL].(2015-04-13)[2019-01-02].https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393978.pdf.
[15]US Food and Drug Administration.The Least Burdensome Provisions of the FDA Modernization Act of 1997:Concept and Principles;Final Guidance for FDA and Industry[EB/OL].(2002-10-04)[2019-01-02].http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf.
[16]US Food and Drug Administration.CDRH Preliminary Internal Evaluations-Volume I:510(k)Working Group Preliminary Report and Recommendations[EB/OL].(2010-8)[2019-01-02].http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf.
[17]US Food and Drug Administration.FDA and Industry Actions on Premarket Notification(510(k))Submissions:Effect on FDA Review Clock and Goals Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2017-10-02)[2019-01-02].http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089738.pdf.
[18]张长虹,秦晓刚,刘宇静,等.对欧美国家医疗器械管理模式的探讨与分析[J].中国医学装备,2006,11(3):5-9.
[19]董春华.美国医疗器械立法嬗变及其动因[J].时代法学,2011,9(5):101-108.
[20]蒙志莹,蔡天智.美国医疗器械产业发展现状及启示[J].中国医疗器械信息,2008,(1):51-54.
[21]潘广成.借鉴美国FDA管理经验加快我国医疗器械立法强化行政管理和监督[J].中国药业,1995,(9):12-13.
[22]温雪君,岑铨华.医疗器械管理过程中存在的问题[J].医疗装备,2017,30(7):89-90.
[23]刘学林,张娇娇,刘海燕.我国在用医疗器械监管中存在的问题及对策研究[J].中国管理信息化,2016,19(24):187-188.
[24]US Food and Drug Administration.Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications(510(k))with Different Technological Characteristics Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2018-09-25)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM404773.
[25]石莉,李非,程茂波,等.美国FDA医疗器械受益-风险评估时需要考虑的因素指南介绍[J].中国医疗器械信息,2018,24(19):1-4+32.
[26]卢爱丽.美国FDA2012财年医疗器械注册新变化[J].中国医疗器械信息,2011,17(10):24-25.
[27]US Food and Drug Administration.Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications[EB/OL].(1998-03-20)[2019-01-02].http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm.
[28]US Food and Drug Administration.Medical Device Classification Product Codes-Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2013-04-11)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm285317.htm.
[29]阮吉敏.中美医疗器械监管的比较与分析[J].国际医药卫生导报,2005,(7):98-105.
[30]孙勤,严梁.欧美医疗器械管理经验及对中国医疗器械法规体系改革的启示[J].中国医疗器械杂志,2006,30(1):43-52.
[31]梁晓婷,池慧,杨国忠.欧洲、美国、日本医疗器械标准管理及对我国的启示[J].中国医疗器械信息,2008,(8):37-52+64.
[2]US Food and Drug Administration.FDA and Industry Procedures for Section 513(g)Requests for Information under the Federal Food,Drug,and Cosmetic Act[EB/OL].(2012-04-06)[2019-01-02].http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209841.htm.
[3]US Food and Drug Administration.User Fees for 513(g)Requests for Information Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2017-10-2)[2019-01-02].http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm209852.htm.
[4]卢爱丽,薛玲,孙京昇.对美国医疗器械监管的研究[J].首都医药,2008,(6):4-6.
[5]屈宝刚.美国医疗器械法规介绍[J].中国医疗器械信息,2005,(1):29-30.
[6]沈翀.美国FDA医疗器械和放射健康中心(CDRH)医疗器械监管模式概述[J].中国医疗设备,2010,25(3):129-131.
[7]张冬娟.美国和欧盟的医疗器械监管[J].中国信息界(e医疗),2012,(7):30-31.
[8]常永亨.美国对高风险医疗器械的审批[J].中国医疗器械杂志,2013,37(2):132-136.
[9]岳伟.我国医疗器械注册制度与美国510K注册的比较[J].中国医疗器械杂志,2009,3(1):51-58.
[10]王兰明,王宿.美国、欧盟医疗器械上市许可管理制度及其启示[J].中国药业,2012,21(24):1-5.
[11]US Food and Drug Administration.The 510(k)Program:Evaluating Substantial Equivalence in Premarket Notifications[510(k)][EB/OL].(2014-07-28)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.
[12]张世庆,邓洁,章金刚.美国医疗器械监管模式概述[J].中国医疗器械信息,2009,15(10):62-66+82.
[13]US Food and Drug Administration.De Novo Classification Process(Evaluation of Automatic Class III Designation)[EB/OL].(2017-10-30)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080197.
[14]US Food and Drug Administration.Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions[EB/OL].(2015-04-13)[2019-01-02].https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393978.pdf.
[15]US Food and Drug Administration.The Least Burdensome Provisions of the FDA Modernization Act of 1997:Concept and Principles;Final Guidance for FDA and Industry[EB/OL].(2002-10-04)[2019-01-02].http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085999.pdf.
[16]US Food and Drug Administration.CDRH Preliminary Internal Evaluations-Volume I:510(k)Working Group Preliminary Report and Recommendations[EB/OL].(2010-8)[2019-01-02].http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM220784.pdf.
[17]US Food and Drug Administration.FDA and Industry Actions on Premarket Notification(510(k))Submissions:Effect on FDA Review Clock and Goals Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2017-10-02)[2019-01-02].http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089738.pdf.
[18]张长虹,秦晓刚,刘宇静,等.对欧美国家医疗器械管理模式的探讨与分析[J].中国医学装备,2006,11(3):5-9.
[19]董春华.美国医疗器械立法嬗变及其动因[J].时代法学,2011,9(5):101-108.
[20]蒙志莹,蔡天智.美国医疗器械产业发展现状及启示[J].中国医疗器械信息,2008,(1):51-54.
[21]潘广成.借鉴美国FDA管理经验加快我国医疗器械立法强化行政管理和监督[J].中国药业,1995,(9):12-13.
[22]温雪君,岑铨华.医疗器械管理过程中存在的问题[J].医疗装备,2017,30(7):89-90.
[23]刘学林,张娇娇,刘海燕.我国在用医疗器械监管中存在的问题及对策研究[J].中国管理信息化,2016,19(24):187-188.
[24]US Food and Drug Administration.Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications(510(k))with Different Technological Characteristics Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2018-09-25)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM404773.
[25]石莉,李非,程茂波,等.美国FDA医疗器械受益-风险评估时需要考虑的因素指南介绍[J].中国医疗器械信息,2018,24(19):1-4+32.
[26]卢爱丽.美国FDA2012财年医疗器械注册新变化[J].中国医疗器械信息,2011,17(10):24-25.
[27]US Food and Drug Administration.Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications[EB/OL].(1998-03-20)[2019-01-02].http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm.
[28]US Food and Drug Administration.Medical Device Classification Product Codes-Guidance for Industry and Food and Drug Administration Staff[EB/OL].(2013-04-11)[2019-01-02].https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm285317.htm.
[29]阮吉敏.中美医疗器械监管的比较与分析[J].国际医药卫生导报,2005,(7):98-105.
[30]孙勤,严梁.欧美医疗器械管理经验及对中国医疗器械法规体系改革的启示[J].中国医疗器械杂志,2006,30(1):43-52.
[31]梁晓婷,池慧,杨国忠.欧洲、美国、日本医疗器械标准管理及对我国的启示[J].中国医疗器械信息,2008,(8):37-52+64.