The Food and Drug Administration (FDA) last month published a final rule classifying medical device data systems (MDDS) as Class I devices. Effective April 18, the rule requires MDDS manufacturers, including health care facilities acting as manufacturers, to register and list the device with the FDA within 90 days and establish a compliant quality system and medical device reporting system for their devices within 12 months. The FDA defines medical device data systems as "off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples include devices that collect and store data from a glucose meter for future use or that transfer lab results to be displayed at a nursing station for future use."
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