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Classified: Next-Gen Sequencing Analyzers, Mobile Glucose Monitoring, Restless-Leg Devices

Executive Summary

FDA issued orders officially finalizing regulatory classifications and special controls for next-generation sequencing analyzers; "secondary display" devices for continuous glucose monitor data; and vibratory counter-stimulation devices for restless leg syndrome. And the agency is working towards formalizing 510(k) exemptions for future devices of these types as well.


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