CLIA  and Waiver by Application

CLIA: Clinical Laboratory Improvement Amendments

  • Regulate laboratory testing and require clinical laboratories certification prior to in vitro diagnostic (IVD) testing
  • Multiple types of CLIA certificates, based on  complexity of diagnostic tests
  • Responsible federal agencies: FDA, CMC, CDC

CLIA  IVD Categorization:

  • By degree of complexity: waived, moderate complexity, and high complexity

CLIA Waiver by Application:

  • For moderate complexity may test
  • Manufacturer may request categorization of the test as waived
  • Provides evidence to FDA that test meets CLIA statutory criteria for waiver


Image credit: FDA

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