Without the actual statement of definicinies, there's not much to this letter other than that they have ten days to be in compliance with... something?
Does anyone know what they are being ask to fix?
Does anyone know what they are being ask to fix?
What is interesting to me is that this is CMS, not the FDA. CMS runs Medicare and Medicaid and is basically saying that if they don't improve their compliance, CMS will stop paying for their lab tests.
See here for a clear breakdown of responsibility among government agencies: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...