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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

by | Nov 30, 2017 | CLIA-lca, Essential, FDA-lca, Lab Compliance Advisor, Lab Safety-lca

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA’s primary role in the CLIA system is to categorize IVDs. Test Category Get CLIA Certificate Meet Quality Standards Submit to Routine Inspections Moderate complexity √ √ √ High complexity √ √ √ Waived √     Last month, the FDA did two things to enhance the transparency of its CLIA activities. 1. Revised Categorization Guidance The FDA issued updated guidance providing more details about the procedures it will use to categorize IVDs and respond to applications for CLIA waivers. Key details: The FDA will try to notify sponsors of an approved IVD’s categorization within two weeks of approval; IVDs approved for home or over-the-counter use will be waived automatically; Makers of IVDs categorized as moderate complexity can apply for a CLIA waiver; To get the waiver, the maker must use clinical and flex studies to show that the test is simple to use and poses "insignificant risk of an erroneous result." 2. Publication of CLIA Waivers The FDA also launched a pilot program to publish summaries of its CLIA Waiver by Application (CW) decisions. In addition to […]

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs.

Test Category Get CLIA Certificate Meet Quality Standards Submit to Routine Inspections
Moderate complexity √ √ √
High complexity √ √ √
Waived √    

Last month, the FDA did two things to enhance the transparency of its CLIA activities.

1. Revised Categorization Guidance
The FDA issued updated guidance providing more details about the procedures it will use to categorize IVDs and respond to applications for CLIA waivers. Key details:

  • The FDA will try to notify sponsors of an approved IVD's categorization within two weeks of approval;
  • IVDs approved for home or over-the-counter use will be waived automatically;
  • Makers of IVDs categorized as moderate complexity can apply for a CLIA waiver;
  • To get the waiver, the maker must use clinical and flex studies to show that the test is simple to use and poses "insignificant risk of an erroneous result."

2. Publication of CLIA Waivers
The FDA also launched a pilot program to publish summaries of its CLIA Waiver by Application (CW) decisions. In addition to enabling the public to see how the FDA reviewed the data, publishing the decision summaries will help test makers prepare their future CW applications, according to the agency.

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