FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA Waivers The first guidance document, “Recommendations for CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices,” explains how sponsors can demonstrate accuracy, i.e., “insignificant risk of erroneous result,” of in vitro diagnostic tests for purposes of obtaining a CLIA waiver. Among other things, it recommends that sponsors use a two-tier approach to demonstrate that their device is robust and has appropriate and effective risk control measures to ensure insignificant risk of an erroneous result: Tier 1: Risk Analysis and Flex Studies. Sponsors should conduct a systematic and comprehensive risk analysis identifying all potential sources of error, including test system failures and operator errors, and which of these errors can lead to a risk of a hazardous situation; and Tier 2: Fail-Safe and Failure Alert Mechanisms. Sponsors should also identify the control measures, including fail-safe and failure alert mechanisms that will reduce risks for each of the sources of error they identify. Then, once the control measures have been implemented, they should (1) verify that each control measure […]

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