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-su...
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.
I guess that this news will put a dampening on innovation in the mobile medical field though ....
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.
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)