Safety Reporting

 

Safety Reporting (INDs)

1)      What documents are required for submitting an IND Safety Report to the FDA?

a)      Cover Letter

b)      Form FDA 1571

c)      Form FDA 3500A

d)     Narrative description of the event, including a discussion of DSMB and IRB  reviews of the incident and outcomes of the event

Please see the link below for the time frame of reporting IND Safety Reports to the FDA.

                  http://www.o3is.pitt.edu/ind


Safety Reporting (IDEs)

What documents are required for submitting an unanticipated adverse device effect report to the FDA?

For IDE’S: Please submit the following:

1)      Cover letter that includes the following:

a)      IDE #

b)      Device Information

c)      Sponsor-Investigator Contact Information

2)      A report of the Unexpected Adverse Device Effect.  The narrative report should include the following:

a)      Description of the event

b)      Summary of UAP/Unexpected Adverse Device Effect, including a discussion of DSMB and IRB reviews of the incident and outcomes of the event.

Please see the link below for the time frame of reporting unanticipated device effects to the FDA.

http://www.o3is.pitt.edu/node/306