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.
What did the clinical trials show?
We will not discuss the results of the clinical trials performed for the 510(k) submission. We can make no claims that the device is safe or effective until we have FDA approval. Certainly, we believed the results were appropriate for the purpose of our 510(k) submission. It’s worth noting that most 510(k)s require no clinical trials. However, the FDA can require a lot of data. This is a gray area in FDA regulations.
How long did you expect the 510(k) process to take?
Here is the regulation regarding the 90 days, for reference:
“Sec. 807.81 When a premarket notification submission is required.
(a) Except as provided in paragraph (b) of this section, each person who is required to register his establishment pursuant to 807.20 must submit a premarket notification submission to the Food and Drug Administration at least 90 days before he proposes to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use which meets any of the following criteria…”
What did the FDA’s letter to MIMvista say?
Here is the relevant portion of the NSE letter:
“We have determined the device is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to any device which has been reclassified into class I (General Controls) or class II (Special Controls).
This decision is based on the fact that your device has a new indication for displaying medical images for diagnostic use on a mobile/portable device…that alters the diagnostic effect, impacting safety and effectiveness, and is therefore a new intended use.
Furthermore, your device has new technological characteristics that could adversely affect safety and effectiveness and raise new types of safety and effectiveness questions…
Therefore, this device is classified by statute into class III (Premarket Approval), under Section 513(f) of the Federal Food, Drug, and Cosmetic Act (Act).”
Briefly, how is a PMA different from 510(k)?
The 510(k) submission demonstrates that a device is at least as safe and effective as, and therefore substantially equivalent to, a legally marketed device. These comparative marketed devices are called predicate devices–devices that themselves have been cleared through their own 510(k) submission, or devices which were marketed before 1976. This 510(k) submission process is used for most class II devices (those that pose a moderate level of risk).
The PMA process is one in which the manufacturer has to demonstrate to the FDA that the class III device is safe and effective through clinical trials. The process is more rigorous than the 510(k), as class III devices are generally considered to pose a more serious level of risk. It is important to note that when a device does not have a predicate and presents new questions of safety and effectiveness, it will typically be promoted to class III, as was the case for our device.
Do you expect other medical apps to get the same treatment from the FDA? Should they? Are others similar enough to MIMVista to warrant it?
I would expect that any medical app submitted to the FDA for 510(k) or PMA would get an equally thorough consideration by the FDA. They are keenly aware of these matters, and are not sitting idly by while technology rushes ahead. You have reported many recent statements from FDA officials which speak to this, and our experience with the agency supports this fact.
There are other applications, similar to ours, which, to our knowledge, have not yet taken the regulatory path. What this means, time will tell.
Are existing FDA regulations sufficient to regulate medical apps? Does the agency need new ones?
For our type of application, I would say the regulations are sufficient. The current push towards transparency and better communication will serve our purpose better than new regulations. What we in industry need is clarity and consistency as to how the existing regulations will be enforced, and to have confidence that the 510(k) and PMA processes will not be destabilized by surprises and unexpected delays.
How has this process affected your company in general?
We have never been involved in anything so peculiar as this. It has been two years, this month, since we created the first version of our app. Two years! For tech-minded people like us, that’s an incredibly long time. The initial thrill has been steadily replaced over these years with a subdued determination. We believe in this technology. We see its benefit. We know it is the future.
What do you think of curious language like “approved for use on iPhone” or “not intended for diagnostic purposes” on other apps’ descriptions?
Honestly, putting “currently approved for use” in a press release about an iPhone medical application, especially in this overly heightened and uncertain regulatory environment, seems misleading and foolish. Sure, it is probably alluding to the approval that Apple gives to put the app on the App Store, but it is worded poorly. Regardless, the FDA is somewhat touchy on using the word “approval” (see Sec. 807.39 and Sec. 807.97).
There is a long history of medical imaging software that has used the “not intended for diagnostic use” disclaimer. I cannot speak for the FDA on this. I can only note that nothing has been done to discourage its use, at least nothing that I am aware of. In the absence of visible action from the FDA’s Office of Compliance, the practice is probably seen as appropriate by those who use it.
What happens next?
We will continue to pursue the necessary legal means to get our product to market.
We have, however, obtained approval to affix the CE marking on the Mobile MIM device by providing evidence to our notifying body that we have met all the essential requirements of the Medical Device Directive 93/42/EEC. Mobile MIM is currently available in the United Kingdom, Australia, Hong Kong, Singapore, and India.
