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:

                IVD Regulatory Assistance

IVD Regulatory Assistance

                        Clinical Laboratory Improvement Amendments (CLIA)
          CLIA Categorizations
          CLIA Waiver by Application
          Public Databases
          Overview of IVD Regulation Home
          Medical Devices
          Device Advice: Comprehensive Regulatory Assistance
          IVD Regulatory Assistance
          Clinical Laboratory Improvement Amendments (CLIA)IVD Regulatory Assistance Clinical Laboratory Improvement Amendments (CLIA)
  
  	
    Share
    Post
    Linkedin

    Email
    PrintClinical laboratory testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) of 1988 (42 USC 263a) and the associated regulations (42 CFR 493) provide the authority for certification and oversight of clinical laboratories and laboratory testing.  Under the CLIA program, clinical laboratories are required to have the appropriate certificate before they can accept human samples for testing. There are different types of CLIA certificates, as well as different regulatory requirements, based on the types and complexity of clinical laboratory tests a laboratory conducts.

Three federal agencies are responsible for administering the CLIA program: the Centers for Medicare & Medicaid Services (CMS), the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role.

**CMS**

Issues laboratory certificates
	Collects user fees
	Conducts inspections and enforces regulatory compliance
	Approves private accreditation organizations for performing inspections, and approves state exemptions
	Monitors laboratory performance of Proficiency Testing (PT) and approves PT programs
	Publishes CLIA rules, regulations, and guidance**FDA**

Categorizes tests based on complexity
	Reviews requests for CLIA Waiver by Application
	Develops rules/guidance for CLIA complexity categorization**CDC**

Provides analysis, research, and technical assistance
	Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
	Conducts laboratory quality improvement studies
	Monitors proficiency testing practices
	Develops and distributes professional information and educational resources
	Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)Resources

Webinar - CLIA Waiver Applications Final Guidance Documents
	Public Databases
	42 CFR 493 - Laboratory Requirements
	Administrative Procedures for CLIA Categorization - Guidance for Industry and Food and Drug Administration Staff (PDF - 124KB)
	Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices  - Guidance for Industry and Food and Drug Administration Staff
	Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Guidance for Industry and Food and Drug Administration Staff

                                                                                  Content current as of:
      07/17/2023
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsIVD Regulatory Assistance

          
                        Clinical Laboratory Improvement Amendments (CLIA)
          CLIA Categorizations
          CLIA Waiver by Application
          Public Databases
          Overview of IVD Regulation
 
 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