You and FDA are going to get pretty cozy before you are granted clearance – the ‘marriage certificate’ in our little analogy.
To complicate matters, this isn’t a traditional marriage between two consenting adults. This is an arranged marriage.
Yes, the law pretty much says you two MUST marry. Or there won’t be any device babies, so to speak.
Therefore, I suggest you meet one another before you meet the pastor.
“Marriage Counseling for Devices”
I’m a ‘marriage counselor’ of sorts: I know a beautiful spot where we can have intimate pre-submission meetings. We can start with softball questions like:
- Does she like the way you filled in the marriage certificate? I’ve known FDA a long time. Lovely girl, but she has a thing about filling out her forms precisely.
Later, we can move on to questions like:
Are you breakthrough enough for her? FDA isn’t easily impressed, but I’ve known a breakthrough pathway suitors who pretty much eloped! (Without a pre-sub, he never would have known.)
Are all the tests necessary? The biocompatibility, the performance testing, and so many more. Your 510(k) predicate may be based on a series of tests that, to you, seem unnecessary. Does FDA see it the same way? Maybe she’ll waive a trial or two.
Like I said: I’m a marriage counselor. But I’m not a miracle worker!
FDA, do you take this medical device…?
Every once in a while, even the most attractive medical device manufacturer finds FDA an elusive bride.
Wouldn’t you rather know up front? Because the conversation is going to come up sooner or later.
That’s the entire point of the pre-submission meeting.
Before you go “all out” trying to impress FDA with your medical device – with your time, money, and resources; with your submission strategy, your product development and testing, talk with FDA.
Make sure you’re in the same place or you might get strung along in a relationship from hell.
Neither of you want that. More likely than not, I – your marriage counselor – can hear what each of you want in the relationship. I can help you find the middle ground on your path to commercialization.
It’s not you, it’s her.
We often assume it’s the manufacturer’s fault when the relationship turns sour. (It often is.)
But FDA is not flawless. Sometimes you may have explained your design or implementation in a dialect she doesn’t understand. (I speak fluent FDA.)
In these cases, I help FDA understand what you meant to say, explaining another way they might understand your product and technology. Sometimes FDA may recognize she’s asking for something unrealistic or inappropriate for a Class II guy like you.
So before you walk down the aisle, put some time on my calendar. I’ll guide you through the process with Southern charm.
Because I don’t want to attend a wedding where you get stood up at the altar.
+ Michelle +