FDA Exempts Medical Device Data Systems from Premarket Notifications
The Food and Drug Administration is issuing a final rule, effective April 18, 2011, 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…
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one format to another according to preset specifications, or display medical device data. FDA is exempting MDDSs from the premarket notification requirements.