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.”

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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