FDA Issues Guidances on Dual 510(k) and CLIA Waiver Applications

The US Food and Drug Administration (FDA) finalized two guidance’s providing recommendation for Dual 510(k) and CLIA Waiver by Application Studies. The purpose of this guidance is to help manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway.

It explains about study designs for generating data that may support both 510(k) clearance and CLIA waiver. FDA accepts this pathway is in many cases the least oppressive and fastest approach for manufacturers to obtain a CLIA waiver at the same time as 510(k) clearance for new In Vitro Diagnostic (IVD) tests. FDA believes increased use of this application pathway will accelerate the process of bringing simple and accurate IVD tests to CLIA-waived settings, which will better serve patients and providers.

FDA announces its final guidance on CLIA waiver application updates the previous final version from 2008 to include changes brought on by Cures to the section of the guidance on demonstrating insignificant risk of an erroneous result.  Apart from technical edits for consistency with the newly amended section V, FDA says the remainder of the guidance remains unchanged from the 2008 version.

This final guidance presents additional and up to date processes for demonstrating that a test meets the statutory criteria for waiver and includes FDA’s revised thinking regarding the appropriate use of related performance between a waived user and a moderately complex laboratory user to show accuracy.

Under CLIA, clinical laboratories have to acquire certificates to perform complicated diagnostic tests, or a waiver from CLIA requirements to perform tests that have an insignificant threat of an erroneous result. Such test consists of ones that have been authorized via FDA for home use or are so simple and accurate that the likelihood of an erroneous result is negligible.