As a certified regulatory grief counselor, I am asked about FDA submission pathways all the time.
These questions typically come from clients who are ready to go to market and think they just need to prepare a few documents to gain FDA market clearance or approval.
Then I get a look at their product, their documentation, and their go-to-market strategy and tell them that going to market is not a realistic goal at the moment.
This is usually followed by a lot of regulatory denial – we don’t need no stinkin’ FDA – a lot more regulatory anger.
When I tell the client that based on their intended use, a full submission is required – that is when the panic sets in.
“Michelle – how do I know whether to choose a PMA? Or a full 510(k) submission? Do we qualify as a de novo? And what the heck are special controls??”
This is when I generally hand the client a brown paper bag and tell them to take slow, deep breaths.
Do you have the same questions?
FDA submission pathways don’t have to be confusing, but there are some definite do’s and don’ts you need to keep in mind if you don’t want to get mired in the mud of regulatory denial.
Listen in on my presentation to the EIT Health alumni group as we discuss how to determine if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission – as well as the basic requirements for each.
Trust me – it’s gonna be alright.
There’s no shortage of submission guidance out there—but translating it into something workable is a different exercise entirely.
If you’re continuing to build out your approach, these may help:
-
Blog: FDA Submission Types, Costs and Timeframes – Which is Right for You?
-
Video:FDA Regulatory Pathways Explained: 510(k), de novo, PMA, Pre-Subs & eSTAR
-
Video: Medical Devices 101: An Entry Level Overview of the FDA
They cover the same ground from slightly different angles—strategy, execution, and the occasional “what not to do.”
Because in this space, knowing the rules is one thing. Applying them well is something else.
