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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
          eMDR Example Scenario. PMA-approved steroid-eluting leadGuidance & Regulatory Information eMDR Example Scenario. PMA-approved steroid-eluting lead
  
  	
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    PrintThe following scenario is intended solely to illustrate how to provide combination product information identified in section V.B.2 of the Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staffin the data fields of the eMDR reporting system. The scenario described below is not intended to provide a comprehensive representation of all information that may be appropriate to include in ICSRs or how to present it, for a given event, report type, or product type, nor to identify all reports that may be required in relation to the events described.

**Scenario.**The Combination Product Applicant receives information that patient J. Doe had a serious infection that was caused by contamination of the implanted combination product. The applicant submits a serious injury report (see 21 CFR 4.102(b) and 803.50). The product, Implant C, has a coating containing the active ingredient, Active C. The product code for the device is DXY (Implantable Pacemaker Pulse Generator).

**Data Elements.**The applicant reviews the Device Problem Codes and identifies “Item Contaminated During Manufacturing Or Shipping FDA 2969 Issue associated with the presence of any unexpected foreign substance found on the surface or in the package materials, which may affect optimal performance for its intended use” as appropriate for the contamination.

The applicant reviews the Patient Problem Codes and identifies “Infection FDA 1930” as appropriate for the adverse event.

In addition to other content appropriate for the report type, the Combination Product Applicant completes the following elements in the ICSR data fields for eMDR as indicated below:

Type of Information (see section V.B.2 of the PMSR guidance)
			Form 3500A Identifier
			eMDR Descriptor
			Element ValueCombination Product Identifier
			Combination Product [Box G.5]
			Combination Product
			YesReport Type(s)
			Type of Report [Box G.7]
			Type_of_Report
			30-day ReportType of Reportable Event [Box H.1]
			Type_of_Reportable_Event
			Serious InjuryPatient Identifier
			Patient Identifier Patient Identifier [Box A.1]
			Patient Identifier
			J. DoeSuspect Medical Device
			Brand Name [Box D.1]
			Brand_Name
			Implant CCommon Device Name [Box D.2]
			Common Device Name
			Implantable Pacemaker Pulse GeneratorProcode [Box D.2b]
			Device Procode
			DXYSuspect Drug Product
			Name [Box C.1]
			Suspect Product(s)
			Active CAdverse Event Coding
			Patient Code
			[Box H.6]
			Patient_Problem_Code
			1930Device Problem Code
			Code Device Code
			[Box H.6]
			Device_Problem_Code
			2969

                                                                                  Content current as of:
      06/25/2019Guidance & 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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