FDA Approval isn’t all you might think it to be according to the may 2017 issue of Popular Science. You can read the article here: http://www.popsci.com/fda-approved-medical-devices
Take away from the article: The FDA needs to modify it’s way of classifying products. Why have a class of products that really has no oversight? “Class I Medical Device” sure does sound important and official. It makes you think you can depend on the device to do what it says it can do. After all, the FDA must have strenuously inspected and tested the item to make sure it is both safe and effective, right? Apparently not. the way it is described in this article, you could make a tinfoil hat to protect you from alien invader brain waves and the FDA would give it a Class I FDA Approval. If that is truly how the process works, then it sounds like the FDA needs to make some changes.
AUTHOR: 1st Place Medical offers a large variety of hospital-grade medical equipment from our South Florida headquarters.