Does FDA require IRB review of off-label use of a legally marketed device?

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No, when a physician uses a legally marketed device outside its labeling to treat a patient and no research is being done, IRB review is not required. Although not required by FDA, an IRB may still decide on its own initiative to review such use.  

Yes, when the off-label use of a legally marketed device is part of a research study collecting safety and effectiveness data involving human subjects, IRB review and approval is required.

About the Author
Proxima CRO Team
Taylor Lunsford
Regulatory Affairs Associate

Taylor Lunsford is a Regulatory Affairs Associate from Houston, Texas and holds degrees from the University of Houston and the Defense Language Institute. Before working with Proxima, he served in the Army as a Mandarin Chinese translator and intelligence analyst.

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