On February 15, 2011, the Food and Drug Administration ("FDA") published a final rule reclassifying Medical Device Data Systems ("MDDS") as Class I medical devices exempt from 510(k) premarket notification requirements. FDA defined MDDS as medical devices that are intended to transfer, store, convert from one format to another according to preset specifications, or display "medical device data." FDA explicitly excluded electronic health record ("EHR") and computerized physician order entry ("CPOE") systems from the MDDS Final Rule. Because MDDS do not "provide new or unique algorithms or functions," FDA concluded that general controls, such as the Quality System Regulations are sufficient to mitigate any risks associated with MDDS.… Continue Reading
