Under the Clinical Laboratory Improvement Amendments (CLIA), the FDA categorizes in vitro diagnostic (IVD) tests by their degree of complexity: waived, moderate complexity, and high complexity.

Tests that are waived by regulation under 42 CFR 493.15(c), or cleared or approved for home use or for over-the-counter use, are automatically categorized as waived following clearance or approval. Otherwise, following clearance or approval, tests may be categorized either as moderate or high complexity according to the CLIA categorization criteria listed in 42 CFR 493.17.

A manufacturer of a test categorized as moderate complexity may request categorization of the test as waived through a CLIA Waiver by Application (CW) submission to FDA. In a CW, the manufacturer provides evidence to FDA that a test meets the CLIA statutory criteria for waiver, 42 U.S.C. § 263a(d)(3).

Since 2017, the FDA has released decision summaries for test systems for which CLIA Waiver by Application (CW) has been approved. Each CW decision summary contains a review of the data submitted by an applicant to support the determination that a test system meets CLIA statutory criteria for waiver, and FDA's justification in approving the CW application. CW decision summaries allow the public to learn how the FDA reviewed an applicant's data to make a CW approval determination and provide information that is useful for manufacturers preparing future CW submissions. For example, CW decision summaries allow manufacturers to see what types of flex studies and clinical studies other applicants conducted so that they may conduct similar studies.

CW decision summaries are posted below as they become available. For questions or comments about CW decision summaries, please contact [email protected].

Additional Information

• Clinical Laboratory Improvement Amendments (CLIA)
• CLIA Waiver by Application
• IVD Regulatory Assistance