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 In this section:

        Blood & Blood Products

Approved Blood Products

                        
                Licensed Products (BLAs)
          New Drug Applications (NDAs)
          Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)


                Substantially Equivalent 510(k) Device Information Home
          Vaccines, Blood & Biologics
          Blood & Blood Products
          Approved Blood ProductsBlood & Blood Products Approved Blood Products
  	
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    PrintThe 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 DocumentsNew Drug Applications (NDAs)

New Drug Applications with Supporting Documents
	Complete List of Currently Approved NDA and ANDA Application SubmissionsPremarket 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 ApplicationsDevelopment & Approval Process

Biologics License Applications (BLA) Process (CBER)
	New Drug Application (NDA) Process (CBER)
	Premarket Approval (PMA) for CBER-Regulated Products
	Premarket Notification 510(k) Process for CBER-Regulated Products
	Investigational New Drug Applications (INDs) for CBER-Regulated ProductsSub-Topic Paragraphs
          Follow CBER
		Division of Communication and Consumer Affairs
			Office of Communication, Outreach and Development
			Center for Biologics Evaluation and Research
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		ocod@fda.hhs.gov
		
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		For Updates on Twitter, follow @fdacber
	Resources for You (Biologics)
			About the Center for Biologics Evaluation and Research (CBER)
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			Recalls (Biologics)
			CBER-Regulated Products: Shortages and Discontinuations
			Biologics Products & Establishments

                                                                                  Content current as of:
      01/27/2021
                  
                   
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Blood ProductsApproved Blood Products                
                          

                        Licensed Products (BLAs)
          New Drug Applications (NDAs)
          Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)


                        Substantially Equivalent 510(k) Device Information
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