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Aah, gotcha. Well if the FDA medical device regulations don’t cover it, is there not still the possibility of some other regulation still effectively covering i
by mygo 9y ago
Aah, gotcha. Well if the FDA medical device regulations don’t cover it, is there not still the possibility of some other regulation still effectively covering it?
For example something like, the way my device functions may not be regulated but the use of my device by a medical provider is regulated.
- nradov 9y agoMost EMRs don't meet the legal definition of a medical device and nothing a provider does can change that. There are a variety of other regulations in this space. You'll have to be more specific about functionality to determine which rules apply.