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Administrative Procedures for CLIA Categorization of In Vitro Diagnostic Tests

This guidance outlines the administrative procedures for CLIA (Clinical Laboratory Improvement Amendments) categorization of In Vitro Diagnostic (IVD) tests. It covers the processes for determining test complexity categories (waived, moderate, or high complexity) and the procedures for manufacturers to request CLIA categorization or waiver.

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By ReguVirta
3 min read

What You Need to Know? 👇

What is CLIA categorization and why is it important for medical device manufacturers?

CLIA categorization determines the complexity level of in vitro diagnostic tests (waived, moderate, or high complexity), which affects what type of laboratory certificate is required to perform the test and impacts market accessibility.

How long does FDA take to provide CLIA categorization for devices under premarket review?

FDA attempts to notify sponsors of CLIA categorization within two weeks of a positive marketing decision for devices under premarket review, such as 510(k) clearance or PMA approval.

What are the performance goals for CLIA Waiver by Application submissions under MDUFA IV?

Under MDUFA IV (FY 2018-2022), FDA aims for 90% substantive interaction within 90 days, 90% MDUFA decisions within 150 days (no panel) or 320 days (with panel), and dual submissions within 180 days.

Can manufacturers request CLIA categorization for devices exempt from premarket notification?

Yes, manufacturers of devices exempt from premarket notification can submit requests for CLIA categorization directly to CDRH Document Control Center, including package insert and test instructions for review.

What is a Dual 510(k) and CLIA Waiver by Application submission?

A Dual submission combines a complete 510(k) premarket notification and CLIA waiver application in a single submission, allowing simultaneous review of marketing clearance and waiver categorization requests.

How can manufacturers get FDA feedback on CLIA waiver study protocols before conducting studies?

Manufacturers can submit planned protocols or study designs through the Pre-Submission process to obtain FDA feedback before conducting CLIA waiver studies, helping ensure appropriate study design and data collection.

What You Need to Do 👇

  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 🔗

Related references and norms 📂

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

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 ID: cf615027a609ad05359c3f54711498b4
FDA guidance, Final
Medical Devices Administrative / Procedural User Fees CLIA (Clinical Laboratory Improvement Amendments)
This post is licensed under CC BY 4.0 by the author.