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)
{"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}
引用次数: 3
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.<>
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