# New FDA program pre-approves tech to speed medical progress

**URL:** https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345
**Category:** D-News
**Tags:** digital-devices, apple, fitbit
**Created:** [October 13, 2017, 6:45pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345 "2017-10-13T18:45:57Z")
**Posts on this page:** 12
**Page:** 1

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### Author: ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)
#### Post date: [October 13, 2017, 6:45pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/1 "2017-10-13T18:45:57Z")

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> [@Freestyle Libre and Blucon as CGM](https://forum.fudiabetes.org/t/freestyle-libre-and-blucon-as-cgm/1367/7):
>
> Nothing that requires FDA approval comes quickly.

[http://fortune.com/2017/09/26/fda-digital-health-apple-fitbit/](http://fortune.com/2017/09/26/fda-digital-health-apple-fitbit/)  
[https://www.theverge.com/tech/2017/9/26/16369212/fda-pre-cert-program-apple-fitbit-health-tech](https://www.theverge.com/tech/2017/9/26/16369212/fda-pre-cert-program-apple-fitbit-health-tech)

FDA announced a new program Tuesday that offers a “fast track” for nine technology companies to gain approval for features in their devices from the origination

The program, called Pre-cert, will include Apple, Fitbit, Samsung, Alphabet-owned Verily, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, and Tidepool.

The Pre-cert program was initially launched on July 27th. The companies that participate must provide access to the methods they use to develop, test, and maintain their products as well as give information to the FDA about how they collect data and maintain quality.

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### Author: ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)
#### Post date: [October 13, 2017, 6:47pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/2 "2017-10-13T18:47:59Z")

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> [@Freestyle Libre and Blucon as CGM](https://forum.fudiabetes.org/t/freestyle-libre-and-blucon-as-cgm/1367/13):
>
> FDA announced a new program Tuesday that offers a “fast track” for nine technology companies to gain approval for features in their devices from the origination

That’s outstanding. I totally missed that.

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### Author: ![Eric](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/eric/32/9209_2.png) [@Eric](https://forum.fudiabetes.org/u/Eric)
#### Post date: [October 13, 2017, 6:56pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/3 "2017-10-13T18:56:55Z")

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This thread is very confusing to me!

` New FDA program pre-approves tech to speed medical progress`

> [@Beacher](#):
>
> The time at which your glucose stays flat and falls no further is the DIA time

> [@Thomas](#):
>
> I find that if you only look at the most visible effect, you underestimate DIA. For us, we can see very clearly stacking effect up to 5 hours and more, but the most visible effect of insulin stops around 215 minutes (+/- of course, as usual)

I will check my BG and come back to it…  
🤔

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### Author: ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)
#### Post date: [October 13, 2017, 7:19pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/4 "2017-10-13T19:19:19Z")

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Darn, Discourse flubbed the thread split with @Thomas’s post ☹ Let me see how to get it back.

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### Author: ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)
#### Post date: [October 13, 2017, 7:29pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/5 "2017-10-13T19:29:40Z")

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> [@Eric](#):
>
> This thread is very confusing to me!

You are just reading it wrong. Try looking sideways while you spin backwards. Then it all makes sense. If it still is not right then you are not spinning fast enough.

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### Author: ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)
#### Post date: [October 13, 2017, 7:30pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/6 "2017-10-13T19:30:31Z")

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@Thomas: your original post got mangled in the thread split, sorry. Can you have a look at it and see if it is back properly?

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### Author: ![Thomas](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/thomas/32/1719_2.png) [@Thomas](https://forum.fudiabetes.org/u/Thomas)
#### Post date: [October 13, 2017, 7:30pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/7 "2017-10-13T19:30:45Z")

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> [@Michel](#):
>
> Let me see how to get it back.

I have faith. @Michel and @CatLady are the Split Masters !!!

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### Author: ![Eric](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/eric/32/9209_2.png) [@Eric](https://forum.fudiabetes.org/u/Eric)
#### Post date: [October 13, 2017, 7:32pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/8 "2017-10-13T19:32:22Z")

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> [@Thomas](#):
>
> You are just reading it wrong. Try looking sideways while you spin backwards. Then it all makes sense. If it still is not right then you are not spinning fast enough.

I just read it again and now it makes perfect sense. So it must have been the spinning. Thanks for the help.

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### Author: ![Jen](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/jen/32/4777_2.png) [@Jen](https://forum.fudiabetes.org/u/Jen)
#### Post date: [October 13, 2017, 7:39pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/9 "2017-10-13T19:39:10Z")

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Considering I just bought a Fitbit Ionic partly for its upcoming medical applications (Dexcom integration and sleep apnea tracking), the fact that Fitbit is included in this is great! Hopefully health applications that are developed aren’t hindered in crossing the border into Canada!!!

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### Author: ![Michel](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/michel/32/387_2.png) [@Michel](https://forum.fudiabetes.org/u/Michel)
#### Post date: [October 13, 2017, 7:51pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/10 "2017-10-13T19:51:15Z")

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> [@Jen](#):
>
> a Fitbit Ionic

I am curious: are you using it for Dexcom integration right now?

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### Author: ![Jen](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/jen/32/4777_2.png) [@Jen](https://forum.fudiabetes.org/u/Jen)
#### Post date: [October 13, 2017, 8:44pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/11 "2017-10-13T20:44:23Z")

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> [@Michel](#):
>
> I am curious: are you using it for Dexcom integration right now?

No, there’s no Dexcom integration yet. They’re saying early 2018 according to a press release. I’m still using the G4, too. I’m going to keep an eye on Nightscout, as I know that’s being worked on by someone already.

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### Author: ![CatLady](https://yyz2.discourse-cdn.com/flex030/user_avatar/forum.fudiabetes.org/catlady/32/36_2.png) [@CatLady](https://forum.fudiabetes.org/u/CatLady)
#### Post date: [October 13, 2017, 9:12pm UTC](https://forum.fudiabetes.org/t/new-fda-program-pre-approves-tech-to-speed-medical-progress/2345/12 "2017-10-13T21:12:53Z")

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Thanks, learning as I go! 😸
