How are Medical Devices Categorized?
The FDA has recognized three (3) class categories of medical devices. • Class I: These are non-life sustaining and the least complicated. Any failure of a class I device poses little risk to the patient. • Class II: This class is more complicated and riskier than class I, but also non-life sustaining. They are subject to specific performance standards. • Class III: Devices in this class sustain or support life, and any failure is life threatening. When a life is put at risk, because of a pacemaker failure, defective heart stent, or malfunctioning pacemaker, the issue of product liability comes into clear focus. Our firm is experienced in the area of products liability, and will investigate the cause of the device’s defect and name any negligent parties. When a product undergoes extensive quality control procedures and still inflicts harm, the negligent parties must be held accountable.
