CLIA Waiver and Dual 510(k) CLIA Waiver Submissions to FDA

CLIA Waiver applications declined significantly after FDA’s CLIA Waiver guidance was published on January 30, 2008. Between 2008 and 2012, FDA reviewed 34 applications for CLIA Waiver and approved 14, sometimes taking years to issue a denial. The cost of performing CLIA Waiver studies, combined with the lengthy review times and likelihood of failure, discouraged companies from bringing new innovations to this critical public health sector.

As a result of MDUFA III, passed by Congress in 2012, FDA began accepting and reviewing Dual 510(k) and CLIA Waiver by Applications, and more companies are taking advantage of this new Dual Pathway, which promises shorter review time and higher success rates. Additionally, the 21st Century Cures Act Directs FDA to revise the section on Accuracy in the CLIA Waiver Guidance by the end of 2017. How will these changes impact CLIA Waiver Application outcomes?