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.”

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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