{"title":"获得FDA批准的艰辛…概述如何获得FDA批准使用计算机技术的医疗设备(最近的经历)","authors":"Albert Paul","doi":"10.1109/ECBS.1988.5441","DOIUrl":null,"url":null,"abstract":"An overview is given of IVAC Corporations' recent experience in getting FDA approval of the Titrator Sodium Nitroprusside Closed-Loop Module-Model 10K, which received FDA premarket approval on December 17, 1987. A chronology of events is presented. Guidelines for facilitating the process are offered.<<ETX>>","PeriodicalId":291071,"journal":{"name":"Proceedings of the Symposium on the Engineering of Computer-Based Medical","volume":"52 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"1988-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"The travail involved in getting FDA approval . . . an overview on what it took to get FDA approval of a medical device with computer technology (A recent experience)\",\"authors\":\"Albert Paul\",\"doi\":\"10.1109/ECBS.1988.5441\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"An overview is given of IVAC Corporations' recent experience in getting FDA approval of the Titrator Sodium Nitroprusside Closed-Loop Module-Model 10K, which received FDA premarket approval on December 17, 1987. A chronology of events is presented. Guidelines for facilitating the process are offered.<<ETX>>\",\"PeriodicalId\":291071,\"journal\":{\"name\":\"Proceedings of the Symposium on the Engineering of Computer-Based Medical\",\"volume\":\"52 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"1988-06-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Proceedings of the Symposium on the Engineering of Computer-Based Medical\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1109/ECBS.1988.5441\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Proceedings of the Symposium on the Engineering of Computer-Based Medical","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1109/ECBS.1988.5441","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The travail involved in getting FDA approval . . . an overview on what it took to get FDA approval of a medical device with computer technology (A recent experience)
An overview is given of IVAC Corporations' recent experience in getting FDA approval of the Titrator Sodium Nitroprusside Closed-Loop Module-Model 10K, which received FDA premarket approval on December 17, 1987. A chronology of events is presented. Guidelines for facilitating the process are offered.<>
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