In the United States, every medical devices need to undergo a Food and Drug Administration process before it can be available for the public to buy. They are then classified according to the level of control that the FDA will need to give to guarantee safety and effectiveness of the device. This classification comes in three categories: Class I, Class II, and Class III.
Medical devices that are under the Class I category are controlled very least by the FDA. These devices are said not to cause any risks of acquiring illness or injury that is why there is less supervision for products included in this category. On the other hand, Class II devices comply with all the regulations that Class I categories go through; they only differ in terms of Class II devices having to go through special controls like requirements for a special label, and postmarket inspection. Furthermore, Class III devices are the one that needs an approval from the FDA before it can be available in the market. For example, the devices under this category need a scientific review in order to try and test the quality of the product to assure that it will not cause any danger to its user.
Whenever we use products that are categorized as Class I devices, we never think about experiencing any injury or illness in the future because these are products that have lower risks of giving complications to its users. However, this is not the case for Poligrip which is classified as a Class I medical device.
Right now, there are a lot of people filing a
Poligrip lawsuit against its manufacturer, GlaxoSmithKline. If you have been using Poligrip and you are experiencing some unexplainable symptoms, contact your lawyer today.
