TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears.
The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA requests more info for TearLab’s eye diagnostic tech appeared first on MassDevice.
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