FDA medical device classification involves placing items into certain categories according to how safe they are. This is very important to the health care industry because the lives of those affected by these devices should be protected. There are certain things that are looked at when placing these items into various categories.
The complexity of the design is one factor that is considered. Some items are designed in a very simple manner and are used for basic procedures while others are more complex, such as toothbrushes. Something that is simple in design might not cause much concern. This is classified as a Class I device But, it will still be subject to general controls, and this is a class I category.
These general controls include keeping an eye on items that are adulterated and devices that are banned. The devices which are placed under general controls are not used to support life and they are usually not a threat to one's health. An example of this is gloves that are used for examination and bandages.
When there are general controls in addition to special controls, this is a class II category. These are devices that are subject to greater standards than those of a class I category. They have to perform in the way they are designed to perform without injuring the user or the patient. An example of this is a powered wheel chair. Class II medical devices require pre-market clearance from FDA. This clearance requires submission of an application referred to as a 510(k).
The next category is class III and this means that in addition to general controls, there is a need for scientific review of these items. These devices are usually used to sustain life or support it in some way. This means that there is the potential to harm the patient if the item is misused. An example of this would be a pacemaker. Class III also requires pre-market clearance in the way of a PMA.
FDA Consultants, especially those welled versed in the regulations, such as attorneys, are best equipped to help maneuver the regulatory issues of FDA for medical devices. An FDA Consultant who has conducted 510(k) applications will be able to assist you in drafting the applications and ensuring that the necessary testing and paperwork is complete before submission.