Clients find lots of creative ways to ruin their FDA submission strategy. Doing their own research is one, and huge no-no from my perspective.
I can’t tell you how many times I’ve had clients derail a strategy because they had done some Googling and had “found a better way” than the slow and steady path we had outlined, which usually involves a detailed clinical plan and months of validation and verification testing.
Too often, they have investors who are expecting a set timeline for launch and refuse to listen to my repeated suggestions that they hold off on submitting to the FDA until they complete all the required testing.
Too often, I end up pleading with them. I bargain. I tear my hair and rip my clothing.
I show them hard evidence of other companies that have done the same thing – and failed.
I highlight the bejeezus out of the guidance documents, trying to make them see reason.
I remind them of the detailed FDA submission strategy that we so painstakingly hashed out together.
All to no avail.
The client merrily sends their (incomplete) 510(k) to the FDA, sits back, and waits impatiently for market clearance.
What they get is a big red DENIED stamp and a not-so-gentle warning from FDA to not waste their time.
Folks – the regulations aren’t optional, and your regulatory consultant is not intentionally misleading you with false information.
Regardless of where you’re from, the FDA doesn’t care about your investors’ dividends, they don’t care about your overly optimistic launch timeline, and they certainly don’t care about your inflated 2023 revenue projections.
This is especially important to remember now that Switzerland has voted to accept FDA cleared or approved devices, because the FDA won’t issue any special dispensation for EU manufacturers.
Read the guidance documents, make sure you have fully checked all the boxes, check again, and ask your consultant to review your submission.
Then, and only then, should you submit to the FDA.
And for the love of all that’s holy, don’t assume that because you’ve “done your own research” you know exactly what needs to be done, because chances are you’re wrong.
Trust me, adhering to your defined FDA submission strategy will be much better for you and your company in the long run.
Here are some other regulatory mistakes to avoid: https://youtu.be/cilqNkmHvFI
And if you’re thinking you can hold off on biocompatibility testing until after you receive market clearance, check this out: https://leanraqa.com/biocompatibility/