Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Biologics Rules

Biologics Rules

                        Blood Notices, Proposed and Final Orders, Proposed and Final Rules
          General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
          Tissue Notices, Proposed and Final Rules
          Vaccine Notices, Proposed and Final Rules Home
          Vaccines, Blood & Biologics
          Guidance, Compliance & Regulatory Information (Biologics)
          Biologics Rules
          General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final RulesBiologics Rules General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintWe have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within Guidances, Rules and other documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title. For more assistance, go to Contact FDA.

Notices

Federal Register Notice: Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program; Request for Comments
	6/21/2022

Proposed Orders

None



Final Orders

Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
	11/9/2023
	Exemption of Certain Categories of Biological Products from Certain Reporting Requirements Under the Federal Food, Drug, and Cosmetic Act
	4/13/2023
	Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
	11/4/2022Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
	6/15/2022Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology
	2/7/2020

Proposed Rules

None



Final Rules

Final Rule: Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
	4/2/2019
	Final Rule: Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
	5/18/2018
	Direct Final Rule: Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Product
	1/26/2018
	Direct Final Rule Withdrawal: Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
	5/7/2018
	Use of Symbols in Labeling
	4/28/2017

                                                                                  Content current as of:
      11/09/2023
              
              
Regulated Product(s)
		 BiologicsBiologics Rules

          
                        Blood Notices, Proposed and Final Orders, Proposed and Final Rules
          General Biologics and Devices, Proposed and Final Orders, Notices, Proposed and Final Rules
          Tissue Notices, Proposed and Final Rules
          Vaccine Notices, Proposed and Final Rules
 Subscribe for CBER Updates
                        Get e-mail updates on What’s New at CBER!
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop