Title :
FDA and the regulation of medical software
Author_Institution :
Food & Drug Adm., Washington, DC, USA
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;
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
DOI :
10.1109/CBMS.1993.262999