Frequently Asked Questions

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

No items found.
IRB: General

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.