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Regulatory Focus™ > News Articles > 2020 > 2 > FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

Posted 25 February 2020 | By Michael Mezher 

FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) waivers for their tests or conduct studies to support dual 510(k) and CLIA waiver by application submissions.
 
FDA first issued draft versions of the guidances in 2017, in line with provisions of the 21st Century Cures Act and the Medical Device User Fee Amendments (MDUFA IV), before revising the draft guidances a year later.
 
Under CLIA, clinical laboratories must obtain a certificate to perform complex diagnostic tests, or a waiver from CLIA requirements to perform tests that have "an insignificant risk of an erroneous result." Such tests include ones that have been approved by FDA for home use or are so simple and accurate that the likelihood of an erroneous result is negligible.
 
When FDA clears or approves in vitro diagnostics, it categorizes the tests as either waived, of moderate complexity or high complexity. Tests that are categorized as waived can be performed by laboratories with a CLIA waiver, while laboratories must have a CLIA certificate to perform moderate and high complexity tests. IVD makers can also request that FDA re-categorize moderate complexity tests as waived through FDA's CLIA waiver by application pathway.
 
CLIA Waiver Applications
 
FDA says its final guidance on CLIA waiver applications updates the previous final version from 2008 to incorporate changes prompted by Cures to the section of the guidance on demonstrating insignificant risk of an erroneous result.
 
“This final guidance provides additional and updated approaches for demonstrating that a test meets the statutory criteria for waiver 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,’” FDA writes.
 
Aside from “technical edits for consistency” in other sections, FDA says the remainder of the guidance remains mostly unchanged from the 2008 version.
 
Dual 510(k) and CLIA Waiver by Application Studies
 
FDA’s final guidance on the studies necessary to support a dual 510(k) and CLIA waiver by application submission is largely the same as the revised draft version released in 2018.
 
FDA explains how to submit a dual submission and the study design considerations an IVD developer should make to support both applications.
 
“Use of the dual 510(k) and CLIA waiver by application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver and at the same time as 510(k) clearance,” FDA writes.
 
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
 
Recommendations for Dual 510(k) and CLIA Waiver by Application Studies

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