# FDA warning for DIY closed-loop systems
**URL:** https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527
**Category:** Type 1 & LADA
**Tags:** closed-loop
**Created:** [May 21, 2019, 12:56am UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527 "2019-05-21T00:56:55Z")
**Posts on this page:** 6
**Page:** 1
### Author:  [@bwschulz](https://forum.fudiabetes.org/u/bwschulz)
#### Post date: [May 21, 2019, 12:56am UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527/1 "2019-05-21T00:56:55Z")
Hopefully this is just the one sternly-worded letter they are required to issue and they won’t actually take any action on this, but posting here for awareness.
Article on statement:
[https://www.bloomberg.com/news/articles/2019-05-17/patient-hurt-by-do-it-yourself-pancreas-prompting-fda-warning](https://www.bloomberg.com/news/articles/2019-05-17/patient-hurt-by-do-it-yourself-pancreas-prompting-fda-warning)
Actual FDA statement:
[https://www.fda.gov/medical-devices/safety-communications/fda-warns-people-diabetes-and-health-care-providers-against-use-devices-diabetes-management-not](https://www.fda.gov/medical-devices/safety-communications/fda-warns-people-diabetes-and-health-care-providers-against-use-devices-diabetes-management-not)
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### Author:  [@Sam](https://forum.fudiabetes.org/u/Sam)
#### Post date: [May 21, 2019, 10:58am UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527/2 "2019-05-21T10:58:33Z")
Hah… F them…
As if people only using the “approved” therapies don’t have “insulin overdoses” sometimes…
Idiotic. I despise the FDA, and I’m not even interested in looping… but certainly hope they don’t manage to screw it up for those who are. Gee here’s an idea… if they’re so concerned about people making their own APs, why don’t they actually approve one that works with Dexcom themselves so people don’t have to cobble together their own systems out of desperation…
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### Author:  [@bkh](https://forum.fudiabetes.org/u/bkh)
#### Post date: [May 22, 2019, 4:19pm UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527/3 "2019-05-22T16:19:55Z")
Katie DiSimone wrote an exceptionally good description/analysis of the underlying incident that lead to the FDA warning, and conclusions to be drawn from it.
[http://seemycgm.com/2019/05/20/fda-warning-against-diy-systems/](http://seemycgm.com/2019/05/20/fda-warning-against-diy-systems/)
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### Author:  [@bpollina](https://forum.fudiabetes.org/u/bpollina)
#### Post date: [May 22, 2019, 11:27pm UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527/4 "2019-05-22T23:27:35Z")
What a wonderful article! The next one on testing wasn’t bad either. Thanks for sharing.
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### Author:  [@bwschulz](https://forum.fudiabetes.org/u/bwschulz)
#### Post date: [May 22, 2019, 11:51pm UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527/5 "2019-05-22T23:51:03Z")
Thanks for the detail/background. Very helpful.
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### Author:  [@docslotnick](https://forum.fudiabetes.org/u/docslotnick)
#### Post date: [May 23, 2019, 12:48am UTC](https://forum.fudiabetes.org/t/fda-warning-for-diy-closed-loop-systems/7527/6 "2019-05-23T00:48:15Z")
The FDA’s reasoning was actually fairly reassuring and valuable. It essentially was an adverse event report, which is to be expected.
The biggest problem, as usual, was what the media did with it.