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FDA Releases Final Guidances for CLIA Waiver Application Study Designs

NEW YORK – The US Food and Drug Administration issued finalized guidance on Tuesday for in vitro diagnostic test manufacturers designing studies for devices for CLIA waiver submissions and dual submissions for 510(k) clearance and CLIA waivers.

The first revised guidance document, "Recommendations for CLIA Waiver Applications for Manufacturers of In Vitro Diagnostic Devices," provides approaches for study designs demonstrating that an IVD test meets required criteria to receive a CLIA waiver. The guidance was revised to implement requirements from the 21st Century Cures Act and the revised section covers how manufacturers may demonstrate the accuracy of a test. It includes four study design options, including comparison and flex studies, and considerations for general study design, such as specimen collection and financial disclosure.

The second guidance document, "Recommendations for Dual 510(k) and CLIA Waiver by Application Studies," is meant to help manufacturers develop study designs for dual submissions and focuses on recommendations for designing a single set of comparison and reproducibility studies.

The dual submission pathway was first established as part of the Medical Device User Fee Amendment of 2012 and allows users to shorten the steps to getting dual 510(k) and CLIA waiver approval by conducting a single set of comparison and reducibility studies with untrained operators to satisfy requirements for both application processes. The draft guidance was originally released in 2017 and updated in 2018.  

For dual submission, the guidance recommends including a device description; a determination that a device is simple to use; results of a risk analysis with potential sources of error identified; failure-alert and fail-safe mechanisms that have been verified to mitigate the risk of errors; flex studies demonstrating insensitivity of the test to environmental and usage variations under stress conditions; descriptions of the design and results of analytical studies, comparison studies, and reproducibility studies; clinical performance studies if necessary; and proposed device labeling. The analytical studies should test sensitivity, measuring interval, specificity, linearity, precision, carry-over, reagent stability, and sample stability.

The recommendations from the FDA are non-binding.