| 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
|
