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        Jurisdictional Information

RFD Jurisdictional Decisions

                        
                Capsular Decisions - Products Assigned to CBER
          Capsular Decisions -  Products Assigned to CDER
          Capsular Decisions - Products Assigned to CDRH
          Redacted Decision Letters Home
          Combination Products
          Jurisdictional Information
          RFD Jurisdictional DecisionsJurisdictional Information RFD Jurisdictional Decisions
  	
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    PrintTransparency in the jurisdictional decision making process is a goal of FDA. Accordingly, FDA is providing redacted RFD decision letters and capsular descriptions of jurisdictional determinations for products that have been approved (refer to web pages listed below). Such transparency in jurisdictional decision making should result in greater predictability and consistency of decisions, and decrease ambiguity and uncertainty about FDA perspectives. Moreover, as the bases for FDA decision making become clearer, the need for formal RFD’s and informal inquiries covering specific products may be diminished, which should conserve resources for both industry and FDA.Capsular Descriptions of Jurisdictional DeterminationsCapsular Decisions - Products Assigned to CBERCapsular Decisions - Products Assigned to CDERCapsular Decisions - Products Assigned to CDRHRedacted Decision LettersRedacted Decision Letters

                                                                                  Content current as of:
      02/16/2018RFD Jurisdictional Decisions                
                          

                        Capsular Decisions - Products Assigned to CBER
          Capsular Decisions -  Products Assigned to CDER
          Capsular Decisions - Products Assigned to CDRH
          Redacted Decision Letters
 
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