FDA Issues Clinical Laboratory Improvement Amendments (CLIA) related Final Guidances

Recommendations for Dual 510(k) and CLIA Waiver by Application Studies | FDA

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices This final guidance describes recommendations for CLIA waiver applications for in vitro diagnostic (IVD) tests.  To implement the 21st Century Cures Act, the FDA revised “Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy” and issued the revisions as a separate draft guidance in 2018.

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Recommendations for Dual 510(k) and CLIA Waiver by Application Studies This final guidance describes study designs for generating data that may support both 510(k) clearance and CLIA waiver. Specifically, this guidance includes recommendations for designing a single set of comparison and reproducibility studies for Dual 510(k) and CLIA Waiver by Application submissions. Read the Guidance Upcoming webinar on these guidances On April 14, 2020, the FDA will host a webinar for industry and others interested in learning more about these guidances. Questions? If you have questions about these final guidances, please contact CLIA@fda.hhs.gov.