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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 Scenario.  BLA-approved product consisting of one vial of biological product along with three device constituent parts: 1) syringe, 2) vial adapter, and 3) sterile needleGuidance & Regulatory Information FAERS Example Scenario.  BLA-approved product consisting of one vial of biological product along with three device constituent parts: 1) syringe, 2) vial adapter, and 3) sterile needle
  
  	
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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 Staff, in 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.**The Combination Product Applicant for BLA 654321, a combination product consisting of one vial of biological product along with three device constituent parts: 1) syringe, 2) vial adapter, and 3) sterile needle, receives information on an event that requires a Fifteen-day report (see 21 CFR 4.102(b) and 600.80). The event was reported by a physician in California and concerned a hemorrhage that resulted in an injury to patient ABC. After submitting the Fifteen-day report for the event, the applicant learns that the event also included a reportable malfunction (see 21 CFR 4.102(c) and 803.50), concerning a broken needle. The applicant submits a Malfunction report as a follow-up report to the initial Fifteen-day report. Subsequent to the Fifteen-day report, based on another report the applicant receives , the applicant determines that the product should be removed to prevent an unreasonable risk of substantial harm to the public health and submits a Five-day report (see 21 CFR 4.102(c) and 803.53). The biological product, Bio B, contains the active ingredient, Active B.  None of the device constituent parts have brand names.

**Data Elements**

The applicant reviews the Device Product Classification Database and is able to identify a product code for the syringe (FMF, Syringe, Piston), vial adapter (ONB, Closed antineoplastic and hazardous drug reconstitution and transfer system) and the needle (FMI, Needle, Hypodermic, Single Lumen).

The applicant reviews the Device Problem Codes and identifies “Fracture FDA 1260 Issue associated with any structural discontinuity in the material; collective term for cracks, splitting etc.” as appropriate for the broken needle.

**Initial ICSR.** In addition to other appropriate content for a Fifteen-day 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 Identifier
			A.1.FDA.15
			<combinationproductreport>
			1 = YesReport Type(s)
			A.1.9
			<fulfillexpeditecriteria>
			1 = 15-DayPatient Identifier
			B.1.1
			<patientinitial>
			ABCReporter Identifier 54
			A.2.1.2e
			<reporterstate>
			CAA.2.1.4
			<qualification>
			1 = PhysicianSuspect Medical Device and Device Problem Code
			B.4.k.20.FDA.2<commondevicename>
			Syringe, PistonB.4.k.20.FDA.3
			<productcode>
			FMFB.4.k.20.FDA.2
			<commondevicename>
			Needle, Hypodermic, Single LumenB.4.k.20.FDA.3
			<productcode>
			FMIB.4.k.20.FDA.17
			<malfunction>
			2 = NoB.4.k.18.6.FDA.2
			<commondevicename>
			Vial AdapterB.4.k.18.6.FDA.3
			<productcode>
			ONBSuspect Drug Product
			B.4.k.2.1
			<medicinalproduct>
			Bio BB.4.k.2.2
			<activesubstancename>
			Active BB.4.k.4.1
			<drugauthorizationnumb>
			BLA 654321Adverse Event Coding
			B.2.i.0
			<primarysourcereaction>
			Capillary Hemorrhage

**Follow-up ICSR.** In addition to other information appropriate for the report type, the Combination Product Applicant completes all the above elements from the initial report AND any additional information for a Malfunction report type in the follow-up ICSR. As reflected in the chart below, in the ICSR data fields for FAERS, among the additional information, the Combination Product Applicant includes the device problem code and the element to identify the report as a Malfunction report and uses the same Manufacturer Control Number (to ensure the report is not misidentified in FAERS as an initial report)1:

Type of Information
			Data Element
			DTD Descriptor
			Element ValueReport Type(s)
			B.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>
			1260Manufacturer Control Number
			A.1.0.1
			<safetyreportid>
			SAME as Initial Report



**Five-Day report.** As reflected in the chart below, (in addition to other information appropriate for the report type), in the ICSR data field for FAERS the Combination Product Applicant completes the element to identify the report as a Five-day report.

Type of Information
			Data Element
			DTD Descriptor
			Element ValueReport Type(s)
			A.1.9
			<fulfillexpeditecriteria>
			4 = 5-Day



1 Although not included as a specific example, follow-up reports in eMDR can be submitted and can include a new report type.  To identify the report as a follow-up, the applicant would check Box G.7 Follow-up #, and indicate the follow-up number (e.g., Enter 1, if this is the first follow-up report).  1

                                                                                  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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