FDA Guidance Genetic Tests for Heritable Markers

FDA “Guidance on Pharmacogenetic Tests and Genetic Tests for Heritable Markers” is at the link provided. Section III.D addresses Software and Validation of Instrumentation. In addition to referring to the general software submission guidance it specifically states: “If applicable, you should describe how computational concerns such as probe saturation level, background correction, normalization, etc., are addressed by the software.”

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