Informatization Situation and Enlightenment of FDA Medical Device Supervision
Lu Ying,Chen Feng and Bu Shi-ming
Information Center of China Food and Drug Administration,Information Center of China Food and Drug Administration,Information Center of China Food and Drug Administration
[1]U.S. Food and Drug Administration. Commemorating the 40th anniversary of the 1976 medical device amendments[EB/OL]. [2017-04-12].https://www.accessdata.fda.gov/scripts/publications/search_result_record.cfm?id=57089 [2]付伟伟,李竹,李非,魏晶. FDA医疗器械指南开发程序介绍[J]. 中国医疗器械信息,2013,12:1-4. [3]康俊生,耿全强. 美国FDA对进口医疗器械产品的要求及应对措施[J]. 中国医疗器械信息,2007,07:29-35. [4]U.S. Food and Drug Administration. Postmarket Requirements(Devices)[EB/OL]. [2014-06-26]. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/default.htm [5]U.S. Food and Drug Administration. Recalls, Corrections and Removals (Devices) [EB/OL]. [2017-08-25]. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/default.htm [6]U.S. Food and Drug Administration. Device Registration and Listing Module (DRLM): Step-by-Step Instructions [EB/OL]. [2016-06]. https://www.access.fda.gov/drlm/help/index.html [7]U.S. Food and Drug Administration. FDA eSubmitter [EB/OL]. [2016-10-21]. http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm [8]U.S. Food and Drug Administration. eCopy Program for Medical Device Submissions [EB/OL]. [2017-09-25]. https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm370879.htm [9]施雯慧,姚捷,赵燕. 美国医疗器械不良事件报告数据库研究[J]. 中国医药导报,2014,28:148-152. [10]U.S. Food and Drug Administration. Medical Device Reporting (MDR) [EB/OL]. [2017-11-07]. https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm [11]U.S. Food and Drug Administration. MedSun: Medical Product Safety Network [EB/OL]. [2017-05-08]. https://www.fda.gov/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/default.htm [12]U.S. Food and Drug Administration. Create a Medical Device Certificate Application (CFG)Step-by-Step Instructions [EB/OL]. [2016-04]. https://www.access.fda.gov/cecats/help/CreateApplication.html [13]U.S. Food and Drug Administration. Medical Device Databases [EB/OL]. [2017-09-19]. https://www.fda.gov/medicaldevices/deviceregulationandguidance/databases/default.htm [14]Taha Kass-Hout. OpenFDA: Innovative initiative opens door to wealth of FDA’s publicly available data [EB/OL]. [2014-06-02]. https://open.fda.gov/update/openfda-innovative-initiative-opens-door-to-wealth-of-fda-publicly-available-data/ [15]包旭. 美国OpenFDA公众健康项目介绍[J]. 中国执业药师,2015,(10):18-22. [16]杨依晗,王广平,高惠君. 美国食品药品监管大数据实践简介及对我国的启示[J]. 上海医药,2017,09:60-65. [17]Duke-Margolis Center for Health Policy. The National Evaluation System for health Technology (NEST): Priorities for Effective Early Implementation [R/OL]. [2016-09]. https://healthpolicy.duke.edu/sites/default/files/atoms/files/NEST%20Priorities%20for%20Effective%20Early%20Implementation%20September%202016_0.pdf [18]U.S. Food and Drug Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices [R/OL]. [2017-08-31]. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf [19] U.S. Food and Drug Administration. Data Standards and Terminology Standards for Information Submitted to CDRH [EB/OL]. [2017-06-05]. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/DataStandardsMedicalDevices/default.htm [20]U.S. Food and Drug Administration. FDA Industry Systems [EB/OL]. [2017-09-25]. https://www.access.fda.gov [21]U.S. Food and Drug Administration. Device Registration and Listing [EB/OL]. [2017-08-02]. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/
