February 10th, 2010

FDA Review Process for Glucose cholestechs

Posted in Other, Travel by Cardiocheck

FDA Review Process for Glucose cholestechs

For an outline of the FDA review process for glucose cholestechs, use the following link:

Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology (Draft Document)

http://www.fda.gov/cdrh/ode/gluc.html

For information about the application of human factors to the design of medical devices, use the following link:

Medical Device Use Safety: Incorporating Human Factors Engineering into Risk Management

http://www.fda.gov/cdrh/humfac/1497.pdf

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