##  [Regulatory Strategy and Submission Services](/case-studies/regulatory-strategy-and-submission-services) 

- [Medical Devices](/case-studies-main-categories/medical-devices)
- [Regulatory Affairs](/case-studies-main-categories/regulatory-affairs-0)





[US FDA](/case-studies-heath-authority/us-fda)

 

 ![Regulatory Strategy and Submission Services]()

The client based in USA is a contract research organization and genome-scale diagnostics Services Company specializing in genome guided medicine​approached Freyr for Regulatory Strategy and submission services. What is section 513 (g)? How Freyr identified the class of the NGS based product?

Read the case thoroughly to have a better understanding of NGS based medical device classification.



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