US FDA Agrees To CLIA Waiver Process Reforms, But More Is Needed, Coalition Says
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.
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More specific details have emerged about the agreement "in principle" announced last week by FDA and industry negotiators on the next round of the medical device user-fee program, which will extend from fiscal years 2018 through 2022.
On April 6, the Senate HELP Committee finished the last of three markup sessions on medical innovation bills designed to be the Senate's version of the 21st Century Cures Act, which passed the House last July. Check out this Gray Sheet chart that lists device-relevant bills that have passed through the HELP Committee aligned with similar House Cures' provisions.
Diagnostic firms formed the Coalition for CLIA Waiver Reform last month with the goal of enlisting patients, labs and physicians in the fight to turn back what they say are unreasonable FDA standards for a test to gain access to the broader market of “waived” labs.