The following products are regulated as Biologics License Applications (BLAs): Fractionated Plasma Products (Alpha-1-Proteinase Inhibitor, Antihemophilic Factor, Antithrombin, C1 Esterase Inhibitor, Coagulation Factors, Fibrin, Fibrinogen, Immune Globulins, Protein C, Thrombin) and Blood Donor Screening Tests for Infectious Diseases and Blood Grouping and Phenotyping.
The following products are regulated as New Drug Applications (NDAS): Solutions used in the collection of blood and plasma donations.
The following products are regulated as Premarket Approvals (PMAs): Devices associated with blood donor testing.
The following products are regulated as 510(k)s: Devices used by the blood banking industry including blood establishment computer software, transfer devices, collection systems, separators, culture bottles, fluid warmers, etc.
Licensed Products (BLAs)
- Fractionated Plasma Products
- Blood Donor Screening
- Infectious Disease Tests
- Blood Grouping and Phenotyping Reagents
- Licensed Biological Products with Supporting Documents
New Drug Applications (NDAs)
- New Drug Applications with Supporting Documents
- Complete List of Currently Approved NDA and ANDA Application Submissions
Premarket Approvals (PMAs)
- Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents
- Complete List of Currently Approved Premarket Applications (PMAs)
Substantially Equivalent 510(k) Device Information
- Cleared 510(k) Submissions with Supporting Documents
- 510(k) Blood Establishment Computer Software
- Complete List of Substantially Equivalent 510(k) Device Applications
Development & Approval Process
- Biologics License Applications (BLA) Process (CBER)
- New Drug Application (NDA) Process (CBER)
- Premarket Approval (PMA) Process (CBER)
- 510(k) Process (CBER)
- Investigational New Drug Applications (INDs) for CBER-Regulated Products
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002
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