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 In order to remain commercially viable - Personalized Medicine Programs providing omics testing services must use appropriate regulatory approved & validated omic testing devices whether results are used to evaluate tumor response, diagnose & treat, evaluate drug response, bioavalibility or biomimetic characteristics.

This means omic medical device manufacturing facilities must adhere to strict quality regulations & GxP manufacturing best practices. 

In the US Omics medical devices & accompanying equipment are regulated by the FDA.  This resource page will be dedicated to identifying & listing
Global Medical Omics Device Regulations, Requirements, Standards & Best Practices not only for the devices themselves, but for the collection, data storage & reporting of patient omic data.

















 

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