Title :
Should government regulate medical software?
Author :
Britain, R.G. ; Paul, J.H.
Author_Institution :
Nat. Electr. Manuf. Assoc., Washington, DC, USA
Abstract :
The role of the US Food and Drug Administration in regulating the software of computer-controlled medical devices is addressed. The FDA draft software review guide´s focus on regulating software aspects rather than system aspects, the licensing of manufacturers or individuals engaged in the software development and the effects of regulation of medical software development on small medical manufacturers and start-ups are discussed.<>
Keywords :
contracts; government policies; medical computing; quality control; software reliability; systems analysis; FDA draft software review; computer-controlled medical devices; licensing; manufacturers; medical software development; small medical manufacturers; software aspects; system aspects; Government; Hazards; Licenses; Manufacturing; Product development; Programming; Quality assurance; Safety devices; Software quality; Software safety;
Conference_Titel :
Computer Assurance, 1990. COMPASS '90, Systems Integrity, Software Safety and Process Security., Proceedings of the Fifth Annual Conference on
Conference_Location :
Gaithersburg, MD, USA
DOI :
10.1109/CMPASS.1990.175420
