Medtech Insight

US FDA Agrees To CLIA Waiver Process Reforms, But More Is Needed, Coalition Says

22 Sep 2016

Despite FDA's efforts to centralize CLIA waiver reviews and bring more consistency to the process, one reform group tied to the diagnostics industry says the agency is not addressing the real problem: the fundamental standard for a waiver determination that FDA established in a 2008 guidance.

US FDA's process for reviewing test-waiver applications under the Clinical Laboratory Improvement Amendments (CLIA) is set to undergo enhancements based on a draft user-fee reauthorization agreement.

In the deal that was inked last month, the agency says it will establish a centralized management group for CLIA...