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I know it's not a 'medical device' (at least in current iteration) but have you read about the FDA taking a look at app stores? http://jkontherun.com/2010/08/31

by jsm386 16y ago

I know it's not a 'medical device' (at least in current iteration) but have you read about the FDA taking a look at app stores? http://jkontherun.com/2010/08/31/fda-has-app-stores-under-surveillance/ http://jkontherun.com/2010/08/31/fda-has-app-stores-under-su...

npsomaratna 16y ago
Thanks for the article. Luckily, the app is (currently) just a fun educational tool and should escape their scrutiny ! I guess that this news will put a dampening on innovation in the mobile medical field though ....
- jacquesm 16y ago
  Not in the third world.
  - npsomaratna 16y ago
    That is very true. However, the problem is that the FDA rules would probably block those apps from being deployed in the US App store. And all said and done, the US App store is key to gaining traction and users.
    - jacquesm 16y ago
      Does the app store allow for geo-targeting ?
      - npsomaratna 16y ago
        Well, there are different App stores for different countries ? Users with US app store accounts will not be able to see apps in other countries app stores (of course, they can just create a new account set to a different country, but your average user is unlikely to do that)
HeyLaughingBoy 16y ago
This is not a surprise to anyone in the industry. There are many small companies out there that market software products that meet the definition of "Medical Device" but are not approved by the FDA or its equivalent in other countries. They escape because they're running under the radar and the agency doesn't have enough people to police everyone. Now put those apps in one or a few places and it becomes much easier to monitor. The solution isn't a simple one. Getting 510(k) submissions (FDA pre-market approval process) approved can be very expensive but at the same time, it's possible that many of the products the FDA regulates really don't need to be or at least could be served by a simpler submission process.

by jsm386 16y ago

npsomaratna 16y ago

Thanks for the article. Luckily, the app is (currently) just a fun educational tool and should escape their scrutiny ! I guess that this news will put a dampening on innovation in the mobile medical field though ....

jacquesm 16y ago
Not in the third world.
- npsomaratna 16y ago
  That is very true. However, the problem is that the FDA rules would probably block those apps from being deployed in the US App store. And all said and done, the US App store is key to gaining traction and users.
  - jacquesm 16y ago
    Does the app store allow for geo-targeting ?
    - npsomaratna 16y ago
      Well, there are different App stores for different countries ? Users with US app store accounts will not be able to see apps in other countries app stores (of course, they can just create a new account set to a different country, but your average user is unlikely to do that)

HeyLaughingBoy 16y ago

This is not a surprise to anyone in the industry. There are many small companies out there that market software products that meet the definition of "Medical Device" but are not approved by the FDA or its equivalent in other countries. They escape because they're running under the radar and the agency doesn't have enough people to police everyone. Now put those apps in one or a few places and it becomes much easier to monitor. The solution isn't a simple one. Getting 510(k) submissions (FDA pre-market approval process) approved can be very expensive but at the same time, it's possible that many of the products the FDA regulates really don't need to be or at least could be served by a simpler submission process.