Home » FDA: Data Gatherers Won’t Need Same OK as Med Devices
FDA: Data Gatherers Won’t Need Same OK as Med Devices
Saying that is providing a “less-burdensome path to market” for low-risk products used with medical devices, the U.S. Food and Drug Administration today set new rules for what it calls Medical Device Data Systems (MDDS) or Class I systems that perform tasks such as storing data collected by a glucose meter or transmitting lab results to a nursing station.
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