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  1. CDRH Transparency

CLIA Waiver by Application Decision Summaries

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 CLIA@fda.hhs.gov.

Test System Name Document
Number
FDA Review
Decision Summary
Effective Date
(MM/DD/YYYY)
Cepheid GeneXpert Xpress System {Xpert Xpress Flu/RSV Assay} (GeneXpert Xpress IV hub configuration), Cepheid GeneXpert Xpress System {Xpert Xpress Flu Assay} (GeneXpert Xpress IV hub configuration) CW190006 Decision Summary 09/30/2019
Sekisui Acucy System {Acucy Influenza A&B Test} (For use with direct nasal and nasopharyngeal swab specimens) CW180008 Decision Summary 12/17/2018
Nova Biomedical Corporation StatStrip Xpress Glucose Hospital Meter System CW180012 Decision Summary 12/13/2018
Nova Biomedical Corporation StatStrip Xpress 2 Glucose Hospital Meter System CW180011 Decision Summary 12/13/2018
Mesa Biotech Accula {Accula RSV Test} CW180006 Decision Summary 11/23/2018
Quidel Sofia 2 (Fingerstick whole blood) CW170015 Decision Summary 08/30/2018
Cepheid Gene Xpert Xpress System {Xpert Flu/RSV Xpress} CW180002 Decision Summary 07/24/2018
StatStrip Glucose Hospital Meter System CW180005 Decision Summary 07/12/2018
Cepheid Gene Xpert Xpress System (Xpert Xpress Strep A) CW170014 Decision Summary 04/26/2018
Alere i System (Alere i Influenza A & B 2) CW170013 Decision Summary 03/23/2018
Mesa Biotech Accula Flu A/Flu B Assay CW170007 Decision Summary 02/06/2018
ACON Laboratories Inc., Mission Cholesterol Pro Monitoring System {Mission Cholesterol Pro Test Cartridges} CW170010 Decision Summary 01/19/2018
Quidel Sofia 2 {Sofia Strep A+ FIA} (from throat swab only) CW170009 Decision Summary 12/21/2017
Cepheid Gene Xpert Xpress System (Xpert Xpress Flu Assay) CW170005 Decision Summary 12/19/2017
Sysmex XW-100 CW170012 Decision Summary 11/06/2017
Alere, BinaxNOW Influenza A & B Card 2 {With Reader} (Direct Nasal and NP Swabs) CW170003 Decision Summary 10/02/2017
Quidel Sofia 2 (Sofia RSV FIA) CW170001 Decision Summary 06/28/2017
Quidel Sofia 2 (Sofia Influenza A+B FIA) CW160016 Decision Summary 05/30/2017

Additional Information

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