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FDA denies CLIA waiver
The FDA has notified TearLab Corp. that the agency cannot approve the company?s Clinical Laboratory Improvement Amendments (CLIA) waiver categorization application for its osmolarity system (TearLab Osmolarity System) based on the data submitted, according to the company
San Diego-The FDA has notified TearLab Corp. that the agency cannot approve the company’s Clinical Laboratory Improvement Amendments (CLIA) waiver categorization application for its osmolarity system (TearLab Osmolarity System) based on the data submitted, according to the company.
“While we are evaluating the FDA’s letter to determine a clear path toward CLIA waiver, we believe that the success of our recently announced Laboratory Director for Moderate Complexity Program gives us the flexibility and time to consider all of our regulatory options,” said Elias Vamvakas, TearLab’s chief executive officer. “With FDA 510(k) approval, Medicare reimbursement, and more than 120 doctors having already completed all of the program steps-20 of which having received their lab director’s certifications to date-we are fully engaged in our U.S. commercialization program.”
The osmolarity system uses a novel lab-on-a-chip approach that requires less than 50 nl of tear fluid to measure tear osmolarity. It can produce a sample-to-answer result in less than 30 seconds, according to the company.
