Choosing the right FDA submission pathway for your device is crucial. But how do you know which one to choose?
Is it a Class I device? Class II? An established technology, or something new? Should you follow a 510K path, or PMA? For a 510K, do you choose the traditional path? Or the abbreviated one? What is the difference between FDA clearance and FDA approval? How long does it take to get through the process?
The targeted 510K approval timeline is 90 days, and the targeted timeline for a PMA is 180 days .
Well, heck, the shorter the better, right? . Getting to market in half the time would sure make your potential investors happy, so that must be the one to choose.
But notice I said targeted. Most 510K submissions take roughly 5 months or more for completion, and PMA submissions can take longer than that.
And there are other differences as well.
A 510K submission will get you a market clearance, based on data from products already on the market. The FDA-approved stamp comes only with a PMA submission, based on FDA review of YOUR data. It is VERY important to understand the difference in order to avoid a nasty letter and charges of mis-branding your device.
And de novo submissions? Well, that is an entirely different bucket of Southern fried chicken, with the possibility of having to do a second submission if the first is denied. Yep – you have to go through the entire process, and pay the fees, all over again.
Then there are the costs. Fees for FDA submissions run in the tens of thousands, depending on the pathway. And that does not include the internal costs associated with running the clinical trials, compiling the data and preparing the submission.
Not exactly something that can be left off your balance sheet when presenting the financials for your investor pitch.
You don’t have to answer these questions on your own. I can clarify the submission options, and help you choose the best pathway for your product. So put some time on my calendar for us to chat and see which strategy makes the most sense for you.