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

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Image credit: FDA