To quote FDA The FDA approval process can take between one week and eight months, depending on whether you self-register, submit a 510(k) application, or submit a Premarket Approval (PMA) application. Bringing a medical device to market is not a fast process.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).
So I think the issue is whether our test and the other tests are equivalent.
In one of the announcements made they claim application for CE can start with Study 6 data, which I think you have missed.
Hope this helps
RHY Price at posting:
$1.44 Sentiment: Hold Disclosure: Held
