The Food and Drug Administration on Feb. 15 will publish a final rule to reclassify Medical Device Data Systems from Class III devices requiring premarket approval to Class I devices regulated under much less stringent general controls.
FDA is exempting such devices from premarket approval “on its own initiative,” and clearly defines the differences between the devices and patient monitoring devices that will remain heavily regulated:
“An MDDS is a device that is intended to transfer, store, convert from one format to another according to preset specification, or display medical device data,” according to the rule. “An MDDS acts only as the mechanism by which medical device data can be transferred, stored, converted or displayed. An MDDS does not modify the data or modify the display of the data. An MDDS by itself does not control the functions or parameters of any other medical device. An MDDS can only control its own functionality. This device is not intended to provide or be used in connection with active patient monitoring. Any product that is intended for a use beyond the use (or functions) identified in this final classification rule is not an MDDS and is not addressed by this rule.”
The rule is available here.
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