IRB Topical Workshop: Device Research and the FDA
Register for this workshopThis online session will detail information about devices and FDA regulations and when they apply.Topics in this session include:Discussions regarding studying the safety and efficacy of a deviceDiscussion of significant/nonsignificant risk devicesDiscussion of IDE, Abbreviated IDE, and IDE ExemptionUse on label or off labelDetail PI obligations should the FDA regulations applyIRB processes…