Clinical Laboratory Improvement Amendments (CLIA)
Clinical Laboratory Improvement Amendments (CLIA)
Diagnostic 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) regulate laboratory testing and require clinical laboratories to be certificated by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
FDA
- Categorizes tests based on complexity
- Reviews requests for Waiver by Application
- Develops rules/guidance for CLIA complexity categorization
- 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 on Proficiency Testing (PT) and approves PT programs
- Publishes CLIA rules and regulations
- 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- Webinar - CLIA Waiver Applications Draft Guidance Documents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- Recommendations for Dual 510(k) and CLIA Waiver by Application Studies - Draft Guidance for Industry and Food and Drug Administration Staff
- Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices - Draft Guidance for Industry and Food and Drug Administration Staff