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Food and Drug Administration, Medical Devices; Medical Device Data Systems; Final Rule, 76 Fed. Reg. 8637, 8648 (Feb. 15, 2011) (full-text).


The Food and Drug Administration (FDA), on its own initiative, issued a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. The FDA exempted MDDSs from the premarket notification requirements.

This rule became effective on April 18, 2011.