If a case with drug and device data submitted using E2B(R2) 2.1 DTD to FDA and now if the follow-up data is received and requires to be processed as Combination Product, what needs to be done from the data entry perspective?

These are the steps to follow to ensure that the case is treated as a Combination Product ICSR:

• Case Classification needs to be set to Combination Product.
• Ensure that the appropriate device information is entered for the device constituents.
• Generate the draft E2B report to the FAERS agency to check if the case qualifies to be Combination Product Case.