How can pumps and CGMs “talk” with eachother? How can my meter send data to my tracking app? These are the kinds of functionality that FDA will someday (soon, hopefully) be called upon to approve in medical devices.
Here’s the link to the PDF of the Draft Guidance: http://www.fda.gov/ucm/groups/fdagov-public/%40fdagov-meddev-gen/documents/document/ucm482649.pdf
Here’s a link to a summary of what the draft guidance says: http://www.fiercemedicaldevices.com/story/fda-releases-guidance-improving-medical-device-interoperability/2016-01-26
Personally, I’m excited to see that “the FDA notes that interoperability can be used to exert command and control over a medical device.” So we’re NOT just talking about transmiting data.
What are your thoughts on this draft guidance?