Chances are you’ve heard a lot about the FDA lately. Maybe it’s the flurry of activity around the pandemic or the growing push for flu vaccines (after all, it’s that time of year when people start getting sick).
Still, if you’ve been looking for PPE lately, the FDA has more than likely been on your mind a lot. Why? Because devices that are approved by the FDA are bound to be products you can trust. A lot goes into getting genuine approval, after all. That’s why we thought we’d break down the basics on how a medical device gets the green light from the FDA.
In order to have a medical device approved by the FDA, a manufacturer first needs to determine which class it is. The classes vary in strictness, from Class I (bandages, gloves, etc.) to Class III (pacemakers, etc.). For the most part, PPE is going to fall under Class I.
However, don’t think that just because PPE is Class I that it gets off easy. No, the FDA strictly regulates medical devices, and that includes Class I products. They aren’t just going to put a stamp of approval on anything.
When the FDA approves a medical device, they’re looking for something that does what it’s supposed to without exposing the user or anyone involved to unnecessary harm. In short, it’s a design that works how you expect it to.
Once a manufacturer develops a great new device, if they have enough data to prove it’s safe and effective, they can submit it for review by the FDA Advisory Committee. If everything’s in order, it’ll be approved! If not, the committee can ask for more information.
The exception to this rule is called a 510(k). Essentially, it means that the device that’s being submitted is similar to other devices that have already received approval. In that case, the device can be approved without the committee’s involvement, but only if it’s safe and effective.
STEWART’s FDA Approved Device
This whole process takes a lot of work, paper, and time. That’s why some medical manufacturers or suppliers don’t go the extra mile.
At STEWART, we don’t let a little work get in the way of your safety. That’s why our Hospitality Patient Pac is FDA Approved. Our Patient Pac includes a bouffant cap, HealthPro 3-ply face mask, and a pair of non-skid shoe covers, all pre-packaged and ready for the next patient’s use.
We’re proud of our distinction and of the quality promise that it brings to our medical device customers. Not only is the Hospitality Patient Pac easy to use and cost effective, but it’s shown to be safe and effective, according to the regulating body of the US. Now that’s something we’re proud of.