Why do some products require Medical Device Authorization to purchase?

Why do some products require Medical Device Authorization to purchase?
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Why do some products require Medical Device Authorization to purchase?

What is medical device authorization?

As we have products and we bring them to market, the manufacturer of that product needs to determine how invasive that product is. So that's how they determine if it needs this symbol, which is the RX symbol. You need a medical director or a physician that oversees the care you're providing to sign off for you to get that item. The way that we determine whether or not it needs RX marking or medical device authorization is the manufacturer of that product, when they actually go to submit for the FDA, there's a set of guidelines that they have to follow and then they make that decision if that's going to be a prescription based one or if that's going to be open for anybody to go ahead and purchase direct.

So how do you purchase something that requires medical device authorization? Well, you'll notice when you go check out that it'll say medical device authorization required. There's a form that you fill out and your medical director must sign off on that. That gets sent in to North American Rescue and that way we're being compliant with the FDA regulations for that device.

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