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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).

To increase transparency into FDA’s decision-making processes, the FDA is piloting the release of CLIA Waiver by Application (CW) Approval Determination Decision Summaries. Each 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. CLIA Waiver Decision Summaries will 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 applications. For example, Decision Summaries allow manufacturers to see what types of flex studies and clinical studies other applicants conducted so that they may conduct similar studies.

During this pilot, CW Decision Summaries will be posted below as they become available. For questions or comments about the CW Decision Summary Pilot, please contact CLIA@fda.hhs.gov.

Test System NameDocument NumberFDA Review Decision SummaryEffective Date (DD/MM/YYYY)
Sekisui Acucy System {Acucy Influenza A&B Test} (For use with direct nasal and nasopharyngeal swab specimens)CW180008CW180008.pdf
Decision Summary
12/17/2018
Nova Biomedical Corporation StatStrip Xpress Glucose Hospital Meter SystemCW180012CW180012.pdf
Decision Summary
12/13/2018
Nova Biomedical Corporation StatStrip Xpress 2 Glucose Hospital Meter SystemCW180011CW180011.pdf
Decision Summary
12/13/2018
Mesa Biotech Accula {Accula RSV Test}CW180006CW180006.pdf
Decision Summary
11/23/2018
Quidel Sofia 2 (Fingerstick whole blood)CW170015CW170015.pdf
Decision Summary
08/30/2018
Nova Biomedical StatStrip Glucose Hospital Meter SystemCW180005CW180005.pdf
Decision Summary
07/12/2018
Cepheid Gene Xpert Xpress System (Xpert Xpress Strep A)CW170014CW170014.pdf
Decision Summary
04/26/2018
Alere i System (Alere i Influenza A & B 2)CW170013CW170013.pdf
Decision Summary
03/23/2018
Mesa Biotech Accula Flu A/Flu B AssayCW170007CW170007.pdf
Decision Summary
02/06/2018
ACON Laboratories Inc., Mission Cholesterol Pro Monitoring System {Mission Cholesterol Pro Test Cartridges}CW170010CW170010.pdf
Decision Summary
01/19/2018
Quidel Sofia 2 {Sofia Strep A+ FIA} (from throat swab only)CW170009CW170009.pdf
Decision Summary
12/21/2017
Cepheid Gene Xpert Xpress System (Xpert Xpress Flu Assay)CW170005CW170005.pdf
Decision Summary
12/19/2017
Sysmex XW-100CW170012CW170012.pdf
Decision Summary
11/06/2017
Alere, BinaxNOW Influenza A & B Card 2 {With Reader} (Direct Nasal and NP Swabs)CW170003CW170003.pdf
Decision Summary
10/02/2017
Quidel Sofia 2 (Sofia RSV FIA)CW170001CW170001.pdf
Decision Summary
06/28/2017
Quidel Sofia 2 (Sofia Influenza A+B FIA)CW160016CW160016.pdf
Decision Summary
05/30/2017

 

Page Last Updated: 03/19/2019
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