10 Similar Device Case Processing (Single Entity Combination Products)

These are the steps for creating/processing cases with Non-US marketed devices that involve reportable malfunction and have similar devices marketed in the US as part of Single entity Combination Product:

1. Book-in a Case with information received as per Source documents.
2. If the Suspect Device had caused a reportable malfunction, then check for the Product Portfolio for Similar devices marketed in the US as Combination Product.
3. If such a product exists, then add the Product from the Product browser and enter the following data in the Drug tab:
   1. Product type = Treatment / Other
   2. Drug not administered = Ticked
4. Enter the following data in the Device tab:
   1. Similar Device = Ticked
5. Select Combination Product in the General > Case Classification field.
6. Save the case and ensure that all mandatory data required for CDER submission is entered.
7. Perform Auto-scheduling and system schedules an E2B report to CDER agency using FDA 2.2 DTD Profile.
8. Click the Draft link to preview the report in XML view.
   The <combinationproductreport> element is populated with value 1, indicating ICSR contains Combination Product.

   The <drugcharacterization> element is populated with value 5, indicating Similar Device.

   The Similar Device data is populated in the ICSR as shown in below example:

   <fulfillexpeditecriteria>5</fulfillexpeditecriteria>
   <combinationproductreport>1</combinationproductreport>
   <drug>
   <drugcharacterization>5</drugcharacterization>
   <medicinalproduct>INSULIN</medicinalproduct>
   <brandname> SYRINGE</brandname>
   <commondevicename>Syringe Piston</commondevicename>
   <productcode>DXT</productcode>
   </drug>