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 In this section:

                Guidance & Regulatory Information

Guidance & Regulatory Information

                        Acts, Rules and Regulations
          Combination Products Guidance Documents
          Intercenter Consultative/ Collaborative Review Process
          Postmarketing Safety Reporting for Combination Products
          Genus v. FDA D.C. Circuit Court Decision and transition from drugs to devices Home
          Combination Products
          Guidance & Regulatory Information
          Reporting Elements for Combination ProductsGuidance & Regulatory Information Reporting Elements for Combination Products
  
  	
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    PrintThe 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 Staffwhen 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 DescriptorCombination 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 eMDR, see eMDR – Electronic Medical Device Reporting webpage.
	For FAERS, see FDA Adverse Event Reporting System (FAERS) Electronic Submissions webpage
	For VAERS, see CBER Vaccine ICSR Implementation webpageFor 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.

                                                                                  Content current as of:
      06/26/2019Guidance & Regulatory Information

          
                        Acts, Rules and Regulations
          Combination Products Guidance Documents
          Intercenter Consultative/ Collaborative Review Process
          Postmarketing Safety Reporting for Combination Products
          Genus v. FDA D.C. Circuit Court Decision and transition from drugs to devices
 
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