3 ms·
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 an
by danielvf 11y ago
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?
- minimaxir 11y agoPer WSJ, that is supposed to be released soon.
- aerovistae 11y agoWhere did you see that?
- minimaxir 11y agohttp://www.wsj.com/articles/problems-found-at-theranos-lab-1453684743 http://www.wsj.com/articles/problems-found-at-theranos-lab-1... (Paywall)
- refurb 11y agoYou can look up the regulations listed in the letter although you won't know exactly what their deficiencies are. 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.
- jforman 11y agoCMS administers the CLIA program. This is about their ability to operate as a lab, not just about Medicare reimbursement. See here for a clear breakdown of responsibility among government agencies: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm124105.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...