12 Similar Device Case Processing (Co-Packaged Combination Products)
These are the steps for creating/processing cases that have Non-US marketed device that involves reportable malfunction and similar devices marketed in the US as part of Co-packaged Combination Product:
- Book-in a Case with information received as per Source documents.
- If the Suspect Device had caused a reportable malfunction, then check the Product Portfolio for Similar devices marketed in the US as Combination Product.
- If such product exists, then add the PMOA Product from the Product browser and enter the following data:
- Product type = Treatment / Other
- Drug not administered = Ticked
- Add the Constituent Device Product from the Product browser and enter the following data:
- Product type = Treatment / Other
- Drug not administered = Ticked
- Similar Device = Ticked
- Select Combination Product in the General > Case Classification field.
- Save the case and ensure that all mandatory data required for CDER submission is entered.
- Perform Auto-scheduling and system schedules an E2B report to CDER agency using the profile selected in the reporting destination EDI tab.
- Click the Draft link to preview the report in XML view.
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For E2B(R2), the <fulfillexpeditedcriteria> element is populated with value 5 indicating a 30-day Malfunction Only report.
For E2B(R3), the <localcriteriareporttype> element is populated with one of the following values indicating the type of report:- 1 = 15-day
- 2 = Non-Expedited
- 4 = 5-day
- 5 = Malfunction (30-day)
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For E2B(R2), the <combinationproductreport> element is populated with value 1 indicating ICSR contains combination product.
For E2B(R3), the <combinationproductreport> element is populated as True.
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For E2B(R2), the <drugcharacterization> element is populated with value 5, indicating Similar Device.
For E2B(R3), the <otherdrugcharacterization> element is populated with value 1, indicating Similar Device.
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The Similar Device data is populated in ICSR.