Regulatory Open Forum

For a non-significant risk IDE, what is the format used for reporting unanticipated adverse events?  Is there a form?  Is it free-form text?  What specific information should be included?  FDA guidance is not much help, as all it says is that it must be reported.  Your help/advice is appreciated.

Hello Anon,

Help to please clarify .. do you have an IDE submission/application in place now or as a non-significant risk device, you only have IRB approval for the study?

For a non-significant risk IDE, what is the format used for reporting unanticipated adverse events?  Is there a form?  Is it free-form text?  What specific information should be included?  FDA guidance is not much help, as all it says is that it must be reported.  Your help/advice is appreciated.