DocumentCode
3488724
Title
FDA and the regulation of medical software
Author
Kim, Paul T H
Author_Institution
Food & Drug Adm., Washington, DC, USA
fYear
1993
fDate
13-16 Jun 1993
Firstpage
1
Lastpage
6
Abstract
This paper traces the development of the Food and Drug Administration´s (FDA) regulation of computer software, as discrete products with medical applications as well as components of regulated medical devices. The earliest Agency deliberations of software are summarized, as are the Agency´s broad policy priorities and the concerns of developers, medical industries, and user communities over the potential scope and consequences of FDA regulation
Keywords
government policies; medical computing; software quality; FDA regulation; Food and Drug Administration; medical software; policy; software quality; software regulation; Biomedical equipment; Computer industry; Drugs; Hardware; Manufacturing; Medical services; Medical treatment; Programming; Quality assurance; Software quality;
fLanguage
English
Publisher
ieee
Conference_Titel
Computer-Based Medical Systems, 1993. Proceedings of Sixth Annual IEEE Symposium on
Conference_Location
Ann Arbor, MI
Print_ISBN
0-8186-3752-8
Type
conf
DOI
10.1109/CBMS.1993.262999
Filename
262999
Link To Document