Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 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
          Including in the ICSR Multiple Entities and/or a Specific Lot Numbers of a Constituent Part of the Combination ProductGuidance & Regulatory Information Including in the ICSR Multiple Entities and/or a Specific Lot Numbers of a Constituent Part of the Combination Product
  
  	
    Share
    Post
    Linkedin

    Email
    PrintCombination Product Applicants may want to include in their Individual Case Safety Report (ICSR) information on more than one entity involved in the manufacture of the combination product and/or a specific lot of a constituent part of the combination product.  The following examples illustrate how such information may be presented when using the FAERS or eMDR reporting system:

**FAERS scenario.** NDA holder PharmComboCo is submitting an ICSR for a co-packaged combination product where the device constituent part is manufactured by DeviceCo.  PharmaComboCo has available information that the device constituent part involved in the event was from DeviceCo lot number DEVCO123 and wants to include this information in the ICSR. The lot number of the co-packaged combination product is COMBO987.To report information on the manufacturer and lot numbers of the device constituent part and the applicant and lot numbers of the co-packaged combination product, PharmaCo completes the following elements in the ICSR data fields for FAERS:

Type of Information
			Data Element
			DTD Descriptor
			Element ValueCombination Product Applicant
			B.4.k.4.3
			<drugauthorizationholder>
			PharmaComboCoDevice Constituent Part Manufacturer
			B.4.k.20.FDA.4a
			<manufacturername>
			DeviceCoLot/batch number of the combination product
			B.4.k.3
			<drugbatchnumb>
			COMBO987Lot/batch number of the device constituent
			B.4.k.20.FDA.16
			<devicelotnumber>
			DEVCO123**eMDR scenario.**  PMA holder ComboMedCo is submitting an ICSR for a single-entity combination product where the lot of the combination product is lot 123, manufactured at a facility operated by ContractCo rather than by ComboMedCo.  ComboMedCo has available information that lot 098 of the drug constituent part was used to manufacture the combination product and wants to include this information in the ICSR.To report information on the applicant, contract manufacturer, and lot numbers of both the single-entity combination product  and the drug constituent part, ComboMedCo completes the following elements in the ICSR data fields for eMDR:

Type of Information
			Form 3500A Identifier
			eMDR Preferred
			Element ValueCombination Product Applicant
			Manufacturer Name [Box D.3]
			Manufacture Name
			ComboMedCoCombination Product Manufacturer
			Contact Office
			[Box G.1]
			Contact Office
			ContractCoLot/batch number of the combination product
			Lot # [Box D.4]
			Lot #
			123Lot/batch number of the drug constituent part
			Lot # [Box C.1]
			Lot #
			[under Suspect Products] 098

                                                                                  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
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop