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Registration and Listing for Firms

Key Topics...
  • Medical Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction
    [Text] [PDF]
  • Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing; Correction
    [Text] [PDF]
  • Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment
    [Text] [PDF]
  • Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction
    [Text] [PDF]
  • Interim Final Rule: Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing
    [Text] [PDF]
  • FDA Press Release Regarding Broader Requirements for Tissue Bank Registration and Listing
  • PDF enabled version of form FDA 2892 - Device listing

Establishment Registration

Foreign Establishment Registration

Other FDA Establishment Registration Internet Sites

Medical Device Listing

Forms

Updated May 7, 2004

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