FDA Watch: Agency Moves to Boost CLIA Waiver Transparency

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

On Oct. 2, 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. The 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 second thing the FDA did to beef up transparency is launch a pilot program under which it will 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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