Did MIMvista ever make it into the AppStore?
Mobile MIM was available at the launch of the App Store. The app was free and included sample patients for people to try it out for themselves.
Why did MIMvista remove the app from the store? (or was it forced out?)
In August of 2008, we submitted our first 510(k). We knew that the iPhone software raised new issues as compared to workstation software, specifically in terms of its intended use. On the iPhone, the images would be viewed under different circumstances than are typical for radiologists (reading rooms). This difference did raise new issues of safety and effectiveness. Changes in intended use and in safety and effectiveness are both reasons for manufacturers to submit a new 510(k).
To be honest, this dramatically new direction for our company, and the speed at which it occurred, left us ill-prepared for the scope of the regulatory process that would unfold. Within only a few weeks of submitting, we were contacted by the FDA and told that our app could not be on the app store (despite the fact that it was both free and labeled as “not intended for diagnostic use”) because it served as marketing for a device that was not cleared for marketing. We promptly removed it.
Then, over the next few months, we discovered that our proposed device raised more questions than we had anticipated. In order to make their determination, the FDA wanted more information than we had provided. The process stalled out as we reviewed what we would have to do next. This 510(k) was declared not substantially equivalent (NSE) because of insufficient data.
We decided to run additional clinical studies to better substantiate our submission. This data took months to gather and prepare, and then on June 24, 2009, we submitted our second 510(k). This time the information provided was significantly more detailed and focused on issues that we believed were of concern to the FDA.
This second 510(k) was uneventful. We received no feedback, questions, or requests for more information. After we reached the 90-day point (the standard review time for the 510(k) process), we inquired and were informed that we had been placed on a 150-day track because of the issues raised in this submission. In the end, however, we did not get the FDA’s decision until after 221 days. We do not know why it went so far beyond the 150 days, but the FDA’s decision came relatively quickly once the radiology group was moved from ODE to OIVD, now under the direction of Donald St.Pierre.
The FDA determined that our medical device was not substantially equivalent to any predicate devices. This NSE letter explained the FDA’s official position that “displaying medical images for diagnostic use on a mobile/portable device” is a new intended use without predicate, and as such is a class III (premarket approval) medical device. We will be starting our PMA investigational clinical trials this year.
Did Apple ever discuss the FDA situation with MIMvista?
They are aware of our situation, and we’ve talked with a few people. However, as the iPhone Developer Program License Agreement clearly states, we are the ones taking the responsibility for compliance with regulations. Apple is not interested in becoming regulated by the FDA.
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