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                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
          FAERS Example Scenarios.  Same or similar device constituent parts.Guidance & Regulatory Information FAERS Example Scenarios.  Same or similar device constituent parts.
  
  	
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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 FAERS 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 1 - Foreign malfunction relevant for US combination product**

**Scenario.** The Combination Product Applicant markets an NDA-approved (NDA 123456) prefilled syringe with integrated needle safety device. The Applicant also markets a combination product outside the US that includes a different drug and the same device. The US product contains drug product, Drug A, which contains the active ingredient, Active A. The foreign product contains drug product, Drug O, which contains the active ingredient, Active O, which is not marketed in the US. Both products contain syringe with integrated needle safety device, SafeSyringe1.

The Combination Product Applicant receives a report for the foreign product that only involves a malfunction that is assumed to be reportable for purposes of this scenario if it were to occur on NDA 123456 (21 CFR 4.102(c) and 803.50). The malfunction was reported by a nurse at XYZ Hospital and involved premature deployment of the needle safety device.

**Data Elements.**  NDA123445 is identified using the “5-similar device” drug characterization and malfunction equals “yes” because the event, if it occurred on the US combination product, would be reportable.

The Combination Product Applicant searches the Device Product Classification Database and identifies product code MEG for “Syringe, Antistick.”

The Combination Product Applicant reviews the Device Problem Codes and identifies Premature Activation FDA 1484 “Problem associated with early and unexpected activation of the device” as appropriate for the malfunction.

Because this was a malfunction-only event, there was no adverse patient reaction. Therefore, the Combination Product Applicant does not identify an adverse patient reaction and uses “NONE” for patient identifier and “No Adverse Event”  in the adverse event coding.

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

Type of Information
			(see section V.B.2 of the PMSR guidance)
			Data Element
			DTD Descriptor
			Element ValueCombination Product Report Identifier
			A.1.FDA.15
			<combinationproductreport>
			1 = YesReport Type(s)
			A.1.9
			<fulfillexpeditecriteria>
			5 = 30-DayPopatient Identifier
			B.1.1
			<patientinitial>
			NONEReporter Identifier
			A.2.1.2a
			<reporterorganization>
			XYZ General HospitalA.2.1.4
			<qualification>
			3 = Other Health ProfessionalSuspect Drug Product
			B.4.k.1
			<drugcharacterization>
			5=Similar DeviceB.4.k.2.1
			<medicinalproduct>
			Drug AB.4.k.2.2
			<activesubstancename>
			Active AB.4.k.4.1
			<drugauthorizationnumb>
			NDA 123456Suspect Medical Device and Device Problem Code
			B.4.k.20.FDA.1
			<brandname>
			SafeSyringe1B.4.k.20.FDA.2
			<commondevicename>
			Syringe, AntistickB.4.k.20.FDA.3
			<productcode>
			MEGB.4.k.20.FDA.17
			<malfunction>
			1 = YesB.4.k.18.6.FDA.19.1a
			<evaluation type>
			01 = Device ProblemB.4.k.18.6.FDA.19.1b
			<evaluationvalue>
			1484Adverse Event Coding
			B.2.i.0
			<primarysourcereaction>
			No Adverse Event

**Scenario 2 - US malfunction for one combination product that could occur in another US-marketed combination product**

**Scenario.** The Combination Product Applicant markets two NDA-approved combination products, NDA1 and NDA2, that contain different drug products, but use the same autoinjector device constituent part. NDA1 contains drug B and active B. NDA2 contains drug C and active C.

The Combination Product Applicant receives a report for NDA1 that involves only a reportable malfunction. For purposes of this scenario, it is assumed that the malfunction would also be reportable if it were to occur on NDA2 (21 CFR 4.102(c) and 803.50). The malfunction was reported by a nurse at XYZ Hospital and involved failure to deliver a dose when the autoinjector was activated.

**Data Elements.**

The event occurred on NDA1, which is identified as “1=Suspect” in the report. Because NDA2 has a similar device for which the malfunction would be reportable if it recurred on the NDA2 product, NDA2 is identified using the “5=Similar device” drug characterization. Malfunction equals “yes” for both because the malfunction that occurred is reportable for both products.

The Combination Product Applicant searches the Device Product Classification Database and identifies product code KZY for “Introducer, Syringe Needle.”

The Combination Product Applicant reviews the Device Problem Codes and identifies Failure to Deliver FDA 2338 “Failure (=complete nonperformance) with regard to the intended function of the device.”

Because this was a malfunction-only event, there was no adverse patient reaction. Therefore, the Combination Product Applicant does not identify an adverse patient reaction and uses “NONE” for patient identifier and “No Adverse Event”  in the adverse event coding.

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

Type of Information
			(see section V.B.2 of the PMSR guidance)
			Data Element
			DTD Descriptor
			Element ValueCombination Product Report Identifier
			A.1.FDA.15
			<combinationproductreport>
			1 = YesReport Type(s)
			A.1.9
			<fulfillexpeditecriteria>
			5 = 30-dayPatient Identifier
			B.1.1
			<patientinitial>
			NONEReporter Identifier
			A.2.1.2a
			<reporterorganization>
			XYZ General HospitalA.2.1.4
			<qualification>
			3 = Other Health ProfessionalSuspect Drug Product
			B.4.k.1
			<drugcharacterization>
			1=SuspectB.4.k.2.1
			<medicinalproduct>
			Drug BB.4.k.2.2
			<activesubstancename>
			Active BB.4.k.4.1
			<drugauthorizationnumb>
			NDA1Suspect Medical Device and Device Problem Code
			B.4.k.20.FDA.2
			<commondevicename>
			AutoinjectorB.4.k.20.FDA.3
			<productcode>
			KZHB.4.k.20.FDA.17
			<malfunction>
			1=YesB.4.k.18.6.FDA.19.1a
			<evaluation type>
			01 = Device ProblemB.4.k.18.6.FDA.19.1b
			<evaluationvalue>
			1484Suspect Drug Product
			B.4.k.1
			<drugcharacterization>
			5=Similar DeviceB.4.k.2.1
			<medicinalproduct>
			Drug CB.4.k.2.2
			<activesubstancename>
			Active CB.4.k.4.1
			<drugauthorizationnumb>
			NDA2Suspect Medical Device and Device Problem Code
			B.4.k.20.FDA.1
			<commondevicename>
			AutoinjectorB.4.k.20.FDA.2
			<productcode>
			KZHB.4.k.20.FDA.3
			<malfunction>
			1=YesB.4.k.20.FDA.17
			<evaluation type>
			01 = Device ProblemB.4.k.18.6.FDA.19.1a
			<evaluationvalue>
			1484

                                                                                  Content current as of:
      04/28/2020Guidance & 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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