Bargaining with the FDA – or trying to – is the third stage of regulatory grief, but adopting that as your strategy will only bring you more grief in the long run.
When dealing with the FDA, it is definitely NOT better to ask forgiveness than permission.
As a medical device manufacturer, you need to accept your fate and head into this arranged marriage gracefully if you want to have a successful submission.
Just as with any other long-term relationship, there are some key things to remember when trying to remain on an even keel with your spouse:
Don’t under-communicate. Hiding information from the FDA doesn’t work any better than hiding ice cream in the freezer or chocolate in the bathroom. You will always be found out, so just do the darn submission and be done with it.
Don’t over-communicate. Three or more pre-submissions won’t do you any good if they are all bad, so just do on, and do it well.
Don’t tune out. This doesn’t work when your mate is asking you to do the dishes, and it doesn’t work when the FDA is trying to guide you in the right direction. Listen to what is being said to you.
Don’t compare – the grass is not always greener. The method a competitor used to bring a product to market won’t necessarily work for you, and it may not have been done properly in the first place. Do your own due diligence…it will pay off in the end.
Don’t try to sweet-talk your way to a 510(k). The FDA really, really, really doesn’t like getting phone calls from prominent politicians who are trying to bribe them into granting approval or clearance for a device. ‘Nuff said.
There truly is no bargaining with the FDA. And trying to sweet-talk your regulatory consultant into doing most of the work required to make that relationship succeed won’t work either.
You’re in this marriage for the duration, so you may as well settle in and find ways to get along with your lawfully-wedded regulator. 😉
Want to see the full explanation? Check out our YouTube channel: https://youtu.be/E-sFfQz4OoI
Still want more? Check out our website: https://leanraqa.com/industries/medical-devices/