13 FAQ

• What type of product configuration is recommended for Combination Products?
  
• In the COMBO_PRODUCT_RELATIONSHIP flexible codelist, is it required to enter Product Name or Trade Name for PMOA and Constituent Products?
  
• Does the Combination Product solution provided by Oracle Argus Safety allow a configuration of Combination Product that comprises of multiple device constituents?
  
• For which type of Combination Products is the flexible codelist configuration required?
  
• If Device is PMOA Product, is it required to configure the combination products in the flexible codelist?
  
• Is MAH required to report cases that contain combination products that include a non-company product as PMOA?
  
• Do the entries populated in the CASE_PMOA_CONS_RELATION table for a case get copied on performing a Case Copy?
  
• 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?
  
• 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 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?
  
• Will there be any impact on any reports submitted outside of US for a case that has Similar device Products?
  
• 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?