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GUIDANCE DOCUMENT

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices Guidance for Industry and Food and Drug Administration Staff February 2020

Final
Docket Number:
FDA-2017-D-5570
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

The Secretary of Health and Human Services has delegated to FDA the authority to determine whether particular tests are "simple" and have "an insignificant risk of an erroneous result" under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and are thus eligible for waiver categorization (69 FR 22849, April 29, 2004). The Centers for Medicare & Medicaid Services (CMS) is responsible for oversight of clinical laboratories, which includes issuing waiver certificates.  CLIA requires that clinical laboratories obtain a certificate before testing  materials derived from the human body. (42 U.S.C. § 263a(b)) Laboratories that perform only tests that are "simple" and that have an "insignificant risk of an erroneous result" may obtain a Certificate of Waiver. (42 U.S.C. § 263a(d)(2).)

Section 263a(d)(3) of CLIA, 42 U.S.C. § 263a(d)(3), Examinations and Procedures, as modified by the Food and Drug Administration Modernization Act (FDAMA), states the following regarding tests that may be performed by laboratories with a Certificate of Waiver:

The examinations and procedures [that may be performed by a laboratory with a Certificate of Waiver]… are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that -- (A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or (B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.

This guidance describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory criteria for waiver described above.

Manufacturers developing devices designed for the CLIA-waived setting have traditionally taken a sequential route, first obtaining FDA clearance or approval and then submitting data for CLIA waiver determination. The Dual 510(k) and CLIA Waiver application (Dual Submission), in which an applicant can apply for 510(k) clearance and CLIA waiver concurrently within one submission, was established as part of the Medical Device User Fee Amendments of 2012 (MDUFA III). Proposed recommendations for Dual Submissions are provided in the guidance "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies."  For more information about CLIA waiver submission options and other administrative details, please see the guidance "Administrative Procedures for CLIA Categorization."

FDA revised this guidance to implement section 3057 of the 21st Century Cures Act (P.L. 114-255), which requires FDA to revise "Section V. Demonstrating Insignificant Risk of an Erroneous Result — Accuracy" of the guidance "Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices" ("2008 CLIA Waiver Guidance") that was issued on January 30, 2008 to include the "appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy." The remainder of this guidance, with exception of technical edits for consistency with the newly amended section V, remains as it was in the 2008 CLIA Waiver Guidance and has not been substantively changed. The guidance provides additional approaches for demonstrating that a test meets the criteria in 42 U.S.C. § 263a(d)(3)(A) and includes FDA's revised thinking regarding "the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy."

This document does not address test systems cleared or approved by FDA for over-the-counter or prescription home use, since these automatically qualify for CLIA waiver. (42 U.S.C. § 263a(d)(3).)

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices."


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Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5570.