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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
          FAR Example Scenario. PMA–approved drug eluting stentGuidance & Regulatory Information FAR Example Scenario. PMA–approved drug eluting stent
  
  	
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    PrintFAR Example Scenario. PMA–approved drug eluting stent

The following scenario is intended solely to illustrate how to provide combination product information identified in section V.B.5 of the Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff in the data fields of the FARs reporting system. The scenario described below is not intended to provide a comprehensive representation of all information that may be appropriate to include in a FAR or how to present it for a given event or product type, nor is it intended to identify all reports that may be required in relation to the event described.

**Scenario.** The Combination Product Applicant for PMA 123456 (P123456), a coronary drug-eluting stent (DES), receives information that the coating on a distributed DES does not meet specifications because of impurities introduced during the stent coating process. The applicant submits a FAR using Form FDA 3331a (see 21 CFR 314.81(b)(1) and 21 CFR 4.102(c)(2)(i)). The device product code applicable to the combination product is NIQ (Coronary Drug Eluting Stent). The DES is branded as Stent A.

**Data Elements.** In addition to other content appropriate for a FAR, the Combination Product Applicant includes the following information in the following data fields for the FAR on Form FDA 3331a. In field 3, the applicant selects the checkbox for “Other” and enters the relevant device application number in the “Number” field (P123456). In field 14, “Remarks,” the applicant identifies the product as a combination product and provides a description of the combination product, including each constituent part, and how, if at all, each constituent part is or may be involved with the issue. The applicant also identifies in the “Remarks” section the device product code (NIQ), the device’s common name (Coronary Drug Eluting Stent), and the brand name (Stent A).

                                                                                  Content current as of:
      07/23/2021Guidance & 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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