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.
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