Noah Wickham

I'm VP of sales and marketing here at my Amazon guy.

I will link this exact article from Amazon support into the description down below if you do want to read more into it.

but they consider it even things sold as over the counter to general consumers.

So sometimes they consider supplements in that same range.

So the product that got dinged over here is a women's health supplement.

And so this is obviously a really, really big deal, especially because normally in the past, anything that was over the counter never had to follow a form of exemption status or had to be considered a medical product at all.

But now for any form of women's health or even vaginal health or anything like that, they are saying that this counts now for the general consumer.

So how do you get around this?

Well, the unfortunate part is it's not going to be easy.

So the FDA has a process for doing this called a five 10 K is a very specific type of exemption process or a labeling process.

More likely I should say around specifically registering your product for this.

I'll link this as well, which is the submission process through the actual FDA website for going through and getting a 510 K number.

It's usually going to be a seven digit code.

Now, once you have your 510 K certification and number, you can take that and submit a review approval for your actual product.

Now, this is also one of those freak situations where Amazon a couple of months ago had thrown out an evaluation where you could basically say, raise your hand, say, Hey, this is not right.

Well, they're not allowing it with this because anything that goes through the FDA has to actually meet a compliance guideline.

And so it's one of the major reasons that Amazon has this.

So you can even look as well under the compliance checklist for medical devices that essentially they are registered with the FDA.

So if you're selling even a women's health supplement and you're not registered, I would.

you either have a class one or class two non exempt medical device cleared by the FDA, you have to have again that 510 K clearance for your product class three, you actually have to go for a pre market approval, which most people shouldn't have to do is if it's just like a supplement or something like that, you also have to have very specific labeling.