On February 25, 2020, the FDA issued two Clinical Laboratory Improvement Amendments (CLIA) Waiver Applications related final guidance documents.
- Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
- Recommendations for Dual 510(k) and CLIA Waiver by Application Studies
The “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” final guidance describes recommendations for CLIA waiver applications for in vitro diagnostic (IVD) tests.
In accordance with 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“Section V. Demonstrating Insignificant Risk of an Erroneous Result – Accuracy” and issued the revisions as a separate draft guidance in 2018. The remainder of this final guidance, except for the Section V revisions, has not been substantially changed from the final guidance “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” issued in 2008.
The “Recommendations for Dual 510(k) and CLIA Waiver by Application Studies” 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.
FDA will host a nationwide webinar on April 14th to explain these guidances and answer pre-submitted questions.
Learn more here: https://www.azbio.org/events/fda-webinar-clinical-laboratory-improvement-amendments-clia-waiver-applications-final-guidances