FDA has recently issued the following guidance documents for developers of in vitro diagnostics. Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.1  This final guidance describes recommendations for CLIA waiver applications for in vitro diagnostics (IVDs). To implement the 21st Century Cures Act, FDA revised ‘Section V. Demonstrating Insignificant Risk of an Erroneous Result–Accuracy,’ and issued the revisions as a separate draft guidance in 2018.

Recommendations for Dual 510(k) and CLIA Waiver by Application Studies.2 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.

Upcoming Webinar on These Guidances 
 
On April 14, 2020, 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 [email protected].
References 
 
  1. Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff. Silver Spring, Md: Center for Devices and Radiological Health, Center for Biologics Evaluation and Research, FDA, 2020. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-clinical-laboratory-improvement-amendments-1988-clia-waiver-applications?utm_campaign=2020-02-25%20FDA%20Issues%20CLIA%20related%20Final%20Guidances&utm_medium=email&utm_source=Eloqua. Accessed March 8, 2020.
  2. Recommendations for Dual 510(k) and CLIA Waiver by Application Studies; Guidance for Industry and Food and Drug Administration Staff. Silver Spring, Md: Center for Devices and Radiological Health, FDA, 2020. Available at: www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-dual-510k-and-clia-waiver-application-studies?utm_campaign=2020-02-25%20FDA%20Issues%20CLIA%20related%20Final%20Guidances&utm_medium=email&utm_source=Eloqua. Accessed March 8, 2020.