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

The US Food and Drug Administration (FDA) 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.

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.

Source: https://www.raps.org/news-and-articles/news-articles/2020/2/fda-finalizes-guidances-on-clia-waiver-application