FDA on Diabetes Interoperability and Artificial Pancreas Progress
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FDA on Interoperability & AP Progress: Where Guidance Can Take Us Courtney H. Lias, Ph.D. Office of In Vitro Diagnostics and Radiological Health Food and Drug Administration
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Transcript of FDA on Diabetes Interoperability and Artificial Pancreas Progress
FDA on Interoperability & AP Progress:
Where Guidance Can Take Us
Courtney H. Lias, Ph.D.Office of In Vitro Diagnostics and Radiological Health
Food and Drug Administration
Devices are a necessary part of managing T1D
And often managing those devices, and making them useful can be frustrating…
But at least the technology you do get is cutting
edge…
And at least there has been progress…
AP Algorithm 1
+ +
AP Algorithm 1
+ +
AP Algorithm 2
+ +
Sensor A
Sensor B
Sensor A
=
=
=
FDAApproval
FDAApproval
FDAApproval
The Current System
Too complicated to succeed…
The Vision:Improve Interoperability
and Make it Feasible
AP Algorithm
AP Algorithm 2
Sensor A
Sensor B
Sensor C
FDAApproval
The VisionPump X
Pump Y
Pump Z
So how do we get there?
Challenge FDA Industry/Scientific Community
Data format Need assurance that devices compatible – standards will facilitate
Need to develop standards?, discuss needs
Secure/Private Communication Protocols
Need assurance that devices secure– standards will facilitate
Standards under discussion, discuss needs
Component device modifications Need assurance that device modifications will not have unintended impact on systems
Need to develop standards?
Postmarket Responsibility Need to define who is responsible in case of component/system failure (investigations, complaints, etc.)
Should provide suggestions/input
Mobile phone capabilities (alarms, app priority, etc.)
FDA encourages use of mobile apps
Need to address current limitations and differences between operating systems
Operating System Updates FDA already has efficient pathway developed
Needs to identify technical challenges to allow multiple systems
Etc… … …
Standardize?!
(gasp!)
FDA Can Help Smooth the Way…
More Discussion to Come
• July 6-7 – session at NIH/FDA/JDRF/Helmsley AP Workshop to intro this topic
• FDA Goals:– Eventual clarity – forward-looking guidance– Influence and encourage change/progress in
industry/Scientific community– Identify gaps/needs
The lead penguin sets the trail so others know where to go….
