I had a very pleasant chat with one of the FDA media specialist and she said that, yes the docket is closed but comments can still be made. Obviously comments will not have the same value to a close docket. So this is what I will send, late. Very late.
- The draft does not create a regulatory path for applications that process information from all the different devices people with diabetes use daily.
- The draft reaches beyond mobile by suggesting regulation cloud based applications, if they are viewable on mobile devices.
- The draft is not clear about the distinctions between logging and analyzing data, particularly from the perspective of diabetes logging.
- Good apps are needed to improve quality of live. Failure to regulate in a timely fashion is a public health risk.
Low Glucose Suspend, a stepping stone to artificial pancreas, is available in virtually every market but the Untied States. However industry could not bring it froward for regulatory consideration in the USA because the FDA was slow to develop LGS guidance to evaluate it. The Agency should avoid following that unfortunate precedent, specifically where a lack of multiple device mobile medical app guidance inhibits AP.
Possible form letters form this.
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