We have more connected health news from FDA (see prior note). The FDA followed through on its deregulatory itrajectory with final guidance on MDDS software and conforming changes to the final guidance on mobile medical apps. MDDS software has been removed from Class 1 regulation. Generally, if the software does nothing more than faithfully transfer information from a medical device, such as a blood pressure device or glucose meter, it is not subject to Class 1 controls. The guidance also extends the category to image transfer and storage software. Links to two stories are here and here and readers may want to sign up for the FDA webinar on February 24th which will cover three recent guidance documents (wellness, accessories, MDDS).
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