1. CDER Combination Product Best Practices
  2. Other Considerations

13 Other Considerations

  1. For submitting a Malfunction report to CDER, these are the recommendations for data entry:
    • Patient tab: No data needs to be entered, Patient Initial element gets populated as None.
    • Product tab: Set the Malfunction field to Yes, enter one or more Malfunctions in the Malfunction Information section and enter the Device Problem codes in the Device tab of the Constituent Product.

      Note:

      If there are multiple malfunction reports, it is recommended to provide a summary of malfunction information in the Narrative.
    • Event tab: Enter No Adverse Event as Reported term to get the properly coded corresponding MedDRA term.
    • Analysis tab: Case Serious is set to No.
  2. For submitting a Malfunction Similar Device report to CDER, the following are the recommendations for data entry:
    1. FDA recommends providing the following data for Similar Device Combination Products. Hence, the FDA E2B report populates this data for Device Combination Products.
      E2B(R2) Element ID E2B(R3) Element ID Element Description
      B.4.k.4.1 G.k.3.1 Authorization/Application Number
      B.4.k.4.2 G.k.3.2 Country of authorization/application
      B.4.k.4.3 G.k.3.3 Name of holder/applicant
      B.4.k.20.FDA.4 FDA.G.k.12.r.7 Manufacturer
      B.4.k.20.FDA.4a FDA.G.k.12.r.7.1a Device Manufacturer Name
      B.4.k.20.FDA.4b FDA.G.k.12.r.7.1b Manufacturer Address
      B.4.k.20.FDA.4c FDA.G.k.12.r.7.1c Manufacturer City
      B.4.k.20.FDA.4d FDA.G.k.12.r.7.1d Manufacturer State
      B.4.k.20.FDA.4e FDA.G.k.12.r.7.1e Manufacturer Country
    2. The following elements are not required for Similar Device Combination Products as the product was not administered, hence it is recommended to leave the following fields blank for FDA E2B(R2) 2.2 reporting:
      E2B(R2) Element ID E2B(R3) Element ID Element Description
      B.4.k.2.4.FDA.1a NA Expiration Date Format
      B.4.k.2.4.FDA.1b NA Expiration Date
      B.4.k.2.FDA.5 NA Product available for evaluation
      B.4.k.2.6.FDA.1a NA Product return date format
      B.4.k.2.6.FDA.1b NA Product return date
      B.4.k.20.FDA.5 NA Model Number
      B.4.k.20.FDA.6 NA Catalog Number
      B.4.k.20.FDA.7 NA Serial Number
      B.4.k.20.FDA.8 NA Unique Identifier UDI#
      B.4.k.20.FDA.9a NA Implanted Date Format
      B.4.k.20.FDA.9b NA Implanted Date
      B.4.k.20.FDA.10a NA Explanted Date Format
      B.4.k.20.FDA.10b NA Explanted Date
      B.4.k.20.FDA.11a NA Approximate age of device/product
      B.4.k.20.FDA.11b NA Approximate age unit of device / product
      B.4.k.20.FDA.12 NA Single Use Device
      B.4.k.20.FDA.13a NA Device Manufacture Date Format
      B.4.k.20.FDA.13b NA Device Manufacture Date
      NA FDA.G.k.12.r.11.r Remedial Action
      B.4.k.20.FDA.14.1a NA Recall
      B.4.k.20.FDA.14.1b NA Repair
      B.4.k.20.FDA.14.1c NA Replace
      B.4.k.20.FDA.14.1d NA Relabeling
      B.4.k.20.FDA.14.1e NA Notification
      B.4.k.20.FDA.14.1f NA Inspection
      B.4.k.20.FDA.14.1g NA Patient monitoring
      B.4.k.20.FDA.14.1h NA Modification/Adjustment
      B.4.k.20.FDA.14.1i NA Other
      B.4.k.20.FDA.15 FDA.G.k.12.r.8 Device Usage
      B.4.k.20.FDA.16 FDA.G.k.12.r.9 Device Lot Number
      NA FDA.G.k.12.r.2.r Followup Type
      B.4.k.20.FDA.18.1a NA Correction
      B.4.k.20.FDA.18.1b NA Additional Information
      B.4.k.20.FDA.18.1c NA Response to FDA request
      B.4.k.20.FDA.18.1d NA Device Evaluation
      B.4.k.20.FDA.19 FDA.G.k.12.r.3.r Device Problem and evaluation codes
      B.4.k.20.FDA.19.1a NA Evaluation Type
      B.4.k.20.FDA.19.1b NA Evaluation Value
      B.4.k.20.FDA.20 FDA.G.k.12.r.10 Operator of the Device