Napoli Bern Ripka, LLP Blog

Medical Devices

When there are flaws in a medical device’s design and/or manufacturing, it can cause injury and even death. A patient looks to these medical devices for help, but in some cases the devices end up hurting rather than helping. The FDA is responsible for the approval and oversight of these devices, and when flaws arise, major problems arise as well. When a patient with a heart murmur is relying on their pacemaker to keep them alive, the workings of the device is crucial to the life of the patient. What would happen if a pacemaker stopped working and left the patient without the support that they needed? In a situation like this, it is important to have a lawyer that has the experience in dealing with large insurance companies, corporations, and the government.

            A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory .Some common medical devices that is useful for diagnostic and therapeutic purposes include:  medical thermometers, blood sugar meters, surgical sutures and X-ray machines. The FDA has recognized three classes of medical devices based on the level of control necessary to ensure the safety and effectiveness of the device. Class 1: general controls (bedpans, examination gloves, & elastic bandages), Class 2: general controls with special controls (surgical needles, wheelchairs, & x-ray machines), Class 3: general controls with premarket approval (replacement heart valves, silicone gel filled breast implants, & implantable pacemaker). The classification procedures are described in the Code of Federal Regulations.