Clinical Laboratory Improvement Amendments (CLIA)

Clinical 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