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

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About the Author
Proxima CRO Team
Taylor Lunsford
Regulatory Affairs Associate
Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

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.

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