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Guidance for Investigational Device Studies

The IRB has posted Guidance for Investigational Device Studies on the Guidance Documents page.  This guidance provides information for investigators to follow in determining whether a study falls under FDA Device Regulations for IRB review and oversight.

Go to the page to review this new document. 

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Research and expertise across CU Boulder.

   

Our 12 research institutes conduct more than half of
the sponsored research at CU Boulder.

More than 75 research centers span the campus,
covering a broad range of topics.

A carefully integrated cyberinfrastructure supports CU Boulder research.