Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
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Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
Internet:	http://www.fda.gov/cdrh/humfac/1497.pdf
Origin/Publisher:	FDA http://www.fda.gov/cdrh/humfac/1497.pdf
Content:	This guidance describes how hazards related to medical device use should be addressed during device development as part of the risk management process.
Status:	Guidance
Document Type:	Guidance