The Food and Drug Administration (FDA) is a government agency in the United States responsible for protecting the public health. The FDA regulates many consumer products, including food, medications, vaccines, medical devices, electronics that emit radiation, cosmetics, veterinary products, and tobacco. Through all the products that the FDA regulates they are divided up into three classes, class I, class II, and class III. The products within these classes are either FDA approved, FDA cleared, and FDA registered. In this post, we will briefly dissect the differences between FDA approved, FDA cleared, and FDA registered.
Products that are considered class I medical products, only need to FDA registered. Products that are minimal risk to the user are registered as class I. 47% of medical products fall into class I. Some products that CAG Federal provides to its clients, such as hand sanitizer, and gowns, fall under class I.
FDA cleared items fall into Class II medical products which are devises that pose a medium risk to the user, where about 43% of medical devises fall into this category. CAG federal supplies gowns that can also be cleared by the FDA. Other example of products that class II include are, motorized wheelchairs, pregnancy test kits, and the Apple Watch ECG app. Before a Class II product can be sold it must show the FDA that it is “substantially equivalent” to another product that the FDA has already given clearance. The reasoning goes that if it’s pretty similar to another “cleared” product then it’s as safe and effective as the other device.
Items that must be FDA approved all come from class III, and makes up about 10% of medical devises. These medical devises impose the most risk to patients. The KN95 mask, which CAG Federal provides, is an example of a FDA approved item. The KN95 mask was formerly FDA registered, but is now FDA approved because of counterfeiting and product not living up to standards in FDA register process. Class III devices also include products like pacemakers, ventilators, breast implants, and replacement heart valves. These devices must submit an application for Premarket Approval (PMA) before marketing. To receive FDA approval for a class III products, manufacturers must demonstrate with sufficient, valid scientific evidence that there is a reasonable assurance that the devices are safe and effective for their intended use.
This article is a helpful quick guideline on how each type of product is regulated by the FDA. CAG Federal is proud to say that many of their products are American made have either been FDA registered, FDA cleared, or FDA approved. Call us today at 877-797-8776 to discuss your current needs!