The FDA’s biocompatibility bouncer will get you every time, no matter how many times you try to sweet-talk your way in.
I’ve seen this happen a thousand times. It’s a classic fake-ID-at-the-door scenario that has tripped up more than a few medical device manufacturers.
In an effort to save time and money, the company does not perform the required cytotoxicity, irritation, and sensitization tests recommended by the FDA’s biocompatibility guidance.
Instead, they try to slip into the 510(k) Club unnoticed, stating that the materials used in their product that have direct contact with patients are perfectly safe, since they are commonly used in medical devices.
Unfortunately, the bouncers at the FDA are as well versed in spotting diversionary tactics as parents of hormonally-charged teenagers, and will always – ALWAYS – come back with the same reply:
“This is not acceptable rationale as the manufacturing process may affect biocompatibility of the materials. Please demonstrate biocompatibility of the patient-contacting components of your device by conducting tests recommended by biocompatibility guidance cited above.”
In other words, you ain’t getting in until you do what I say, and if it isn’t documented, it didn’t happen.
Do your due diligence. Save yourself the aggravation of an FDA-induced curfew and have all the required testing done before trying to get in the door.
It’s their house, their rules, and they’re not going to bend them just for you, because there’s no bargaining with the FDA: https://leanraqa.com/bargaining-with-the-fda/
And just in case you’ve got a few other diversionary tricks up your sleeve, check out these regulatory DON’Ts that have stopped other manufacturers in their tracks: https://youtu.be/cilqNkmHvFI