Published Tuesday 15 Feb in the Federal Register are FDA’s rules on medical device data systems (MDDS) that transfer, convert or display data from the restricted Class III (premarket approval required) to the far less so Class I (general controls). MDDS is not supposed to be used in active patient monitoring. No need to hunt around on the Register–it’s right here: Federal Register filing. Hat tip to Bradley Merrill Thompson of Epstein, Becker.
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In the FDA response to Comment 10, is it correct that they are saying that if the data is displayed in a chart or spread sheet format it would fall under the regulation, but if it is just numbers it would not?