Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests

Recommended Actions

1. Submit CLIA categorization request with premarket submission or separately for exempt devices
2. Include complete package insert with test instructions
3. Use eCopy program for submissions when possible
4. Submit updated labels when device name, manufacturer, or distributor changes
5. Consider pre-submission meeting for CLIA Waiver applications
6. For dual 510(k) and CLIA Waiver applications, inform FDA through pre-submission
7. Maintain awareness of performance goals and timelines for submissions
8. Prepare for interactive review process if issues arise
9. Keep track of assigned CLIA Record (CR) numbers
10. Monitor public CLIA database for categorization status

Key Considerations

Clinical testing

• Clinical laboratory testing requires CLIA certification before accepting human body materials for diagnostic purposes
• Three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests

Labelling

• Package insert test instructions are reviewed to determine test complexity using criteria in 42 CFR 493.17
• Updated labels should be submitted when device name, manufacturer, or distributor changes

Other considerations

• CLIA categorization is determined during premarket review (510(k), PMA, BLA)
• Separate CLIA Record (CR) tracking number is assigned
• Performance goals for CLIA Waiver applications include specific review timelines
• Interactive review process with FDA for unresolved issues
• Pre-submission option available for protocol review
• eCopy submission strongly encouraged

  Relevant Guidances

• CLIA Waiver Applications for In Vitro Diagnostic Devices - Demonstrating Simplicity and Insignificant Risk of Erroneous Results
• Dual 510k and CLIA Waiver by Application for In Vitro Diagnostic Tests

Related references and norms

• 42 CFR Part 493: Laboratory Requirements
• 42 CFR 493.17: Test categorization criteria
• 42 CFR 493.15: Waived tests regulations

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Original guidance

• Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests
• HTML / PDF
• Issue date: 2017-10-02
• Last changed date: 2020-03-02
• Status: FINAL
• Official FDA topics: Medical Devices, Administrative / Procedural, User Fees, CLIA (Clinical Laboratory Improvement Amendments)
• ReguVirta summary file ID: cf615027a609ad05359c3f54711498b4