Regulation and Cyber-Security of Our Diabetes Devices

Medical devices and the data they generate are in the spotlight of late, and this is essentially great news for those of us whose lives are entwined with these systems!

On June 20, FDA released a new draft guidance document outlining their current thinking on how they plan to enforce regulations re: Medical Device Data Systems (MDDS), as part of their medical device innovation initiative.

This guidance proposes the agency use their “enforcement discretion” to “down-classify“* many medical device data systems, including a variety of software applications used to view, track and analyze health data generated by medical devices — which is big win for us D-advocates who’ve been pushing for more open policies that could free up device companies and third-party developers to create more useful software for us to access our device data and better manage our care!

(*Down classification means these items are considered lower-risk to patients, and therefore require less strict regulation. See illustration below)

The agency wants and needs to hear from the diabetes community about the draft guidance, and we need your support!  While the direction of the draft guidance is distinctly positive, there are many points that still need to be clarified.

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