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)
Author_Institution :
IVAC Corp., San Diego, CA, USA
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
Keywords :
medical computing; FDA approval; IVAC Corporations; Titrator Sodium Nitroprusside Closed-Loop Module; computer technology; medical device; Animals; Biomedical monitoring; Business; Computer industry; Control systems; Drugs; Food technology; Pharmaceutical technology; Servomechanisms; Testing;
Conference_Titel :
Engineering of Computer-Based Medical Systems, 1988., Proceedings of the Symposium on the
Conference_Location :
Minneapolis, MN
Print_ISBN :
0-8186-4863-5
DOI :
10.1109/ECBS.1988.5441
