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posted by Cardiocheck on Jul 8

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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