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  1. Guidance & Regulatory Information

Reporting Elements for Combination Products

The table below identifies the data fields for the combination product information described in section IV.B.2 of the Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff when using the FDA Adverse Event Reporting System (FAERS) or the Electronic Medical Device Reporting system (eMDR). 

Type of Information Form 3500A eMDR Preferred Term  FAERS DTD Descriptor
Combination Product Report Identifier Box G.5  Combination Product  <combinationproductreport>
Report Type(s) (e.g., Fifteen-day, Five-Day) Box G.7 (15-day, 5-day) Type_of_Report  <fulfillexpeditecriteria>
Identify as a Malfunction Report Box H.1 (Malfunction)  Type_of_Reportable_Event <malfunction>
Patient Identifier Box A.1 Patient Identifier <patientinitial>
Reporter Identifier Box E  Type_of_Reporter  <primarysource>
Suspect Drug Product(s) Box C.1  Suspect Product(s)

<medicinalproduct>

<activesubstancename>

<drugauthorizationnumb>
Suspect Medical Device(s) Box D.2  Common Device Name <commondevicename>
Box D.2b Device Procode1 <productcode>
Box D.1 Brand_Name <brandname>
Adverse Event Terms

Box H.6 (Device Application)

Box G.8 (NDA/ANDA/BLA)

 Patient_Problem_Code <primarysourcereaction>
Device Problem Code Box H.6 Device_Problem_Code

<evaluation type>

<evaluationvalue>

Reporters should refer to current technical specifications and other documents for detailed instructions for how to complete and submit electronic ICSRs:

For examples of how to present combination product information in Individual Case Safety Repots, see Combination Product PMSR Examples.

1 FDA maintains a searchable online procode database (that includes both procodes and device common names). See also Device Product Codes for Device Constituent Parts of ANDA/NDA/BLA Combination Products. The Combination Product Applicant may contact CDRH’s Division of Industry and Consumer Education (DICE) (DICE@fda.hhs.gov), as well as the Office of Combination Products (OCP) (combination@fda.gov), as needed for assistance in determining the product code that most closely aligns with their device constituent part. 

 

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