CLIA Compliance - United States Only

Currently the TearLab Osmolarity System is categorized as a "moderately complex" device, although the FDA is now reviewing it for re-categorization as a "waived" device.

Once categorized as a "waived" device, each TearLab customer will have the option of obtaining a CLIA waived certificate by submitting a simple CMS-116 form.

TearLab Corporation will provide public notification if the TearLab Osmolarity System has received Waiver categorization. In addition, this website will provide complete instructions on how to obtain a CLIA Waiver certificate using the CMS-116 form.

For additional information regarding the TearLab Osmolarity System and CLIA please contact regulatory@tearlab.com.