14 FAQ
What type of product configuration is recommended for Combination Products?
If the PMOA Product is a single device constituent, then the product can be configured according to the steps suggested for the single entity combination products. However, if there is a requirement to perform assessment of drug and devices separately in the case, then it is recommended to configure the PMOA and device constituents under different products.
If the PMOA Product has a multiple device constituents, then the product can be configured as per the steps suggested in the co-packaged combination products.
In the COMBO_PRODUCT_RELATIONSHIP flexible codelist, is it required to enter Product Name or Trade Name for PMOA and Constituent Products?
It is required to specify the Product Name, not the Trade Name.
Does the Combination Product solution provided by Oracle Argus Safety allow a configuration of Combination Product that comprises of multiple device constituents?
If the Combination Product comprises of multiple device constituents, then it is required to create separate entries for each of the device constituent in the COMBO_PRODUCT_RELATIONSHIP codelist with the same PMOA Product.
For which type of Combination Products is the flexible codelist configuration required?
- Company Drug / Biologic (PMOA Product) and Company Device (Constituent Product)
- Company Vaccine (PMOA Product) and Company Device (Constituent Product)
If Device is PMOA Product, is it required to configure the combination products in the flexible codelist?
For the products with Device as a PMOA Product, eMDRs are required to be submitted. eMDRs do not require configuration of flexible re-categorization codelists for combination products since the eMDR profile maps suspect drugs present in the case to Block C of the report.
Is MAH required to report cases that contain combination products that include a non-company product as PMOA?
MAH is not required to report cases that contain combination products that include a non-company product as PMOA to the FDA.
Do the entries populated in the CASE_PMOA_CONS_RELATION table for a case get copied on performing a Case Copy?
No, Case Copy does not copy the data from the CASE_PMOA_CONS_RELATION table. The data present in this table is neither printed in Case Form Print, nor is it audit logged.
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?
- 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.
If a PMOA Product has multiple device constituents associated, is it required to enter all the device constituents in the case in order to recognize the product as Combination Product?
If the case has PMOA Product along with at least one device constituents present, then it is considered as a Combination Product, and the system does not expect all device constituents to be entered in the case.
If a foreign (Non-US) case has a combination product which has equivalent US licensed combination products, will the system be able to determine that case qualifies for combination product reporting in US?
Yes, the system evaluates the products within the case and compares all licenses associated with the product with the entries in the flexible codelist, and determines if it is a combination product or not.
Will there be any impact on any reports submitted outside of US for a case that has Similar device Products?
Similar device products are entered with product type as Treatment/Other, hence this product is not reflected in any other expedited or periodic reports.
If multiple combination products similar to the device constituent marketed outside of the US resulted in reportable malfunction, is it required to provide the details of the combination product in the E2B report?
Yes, FDA recommends that the report for a foreign malfunction identifies each US combination product (using the Similar characterization) for which the malfunction event being reported is relevant.