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Medical Device Registration

Medical device registration offers a single place for patients to learn about registered devices and provides information about recalls. Medical devices include a wide range of products that vary in complexity and application. The Food and Drug Administration recognizes three classes of medical devices based on the level of control necessary in order to assure the safety and effectiveness of the device. An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure or enhance an existing biological structure. Medical implants are manufactured devices. The surface of implants that come in contact with body might be made of a biomedical material such as titanium, silicone or apatite, depending on what is the most functional. In some cases, implants contain electronics e.g. artificial pacemaker and cochlear implants. Some implants are bioactive, such as subcutaneous drug delivery devices in the form of implantable pills or drug-eluting stents. Among the most common types of medical implants are pins, rods, screws and plates used to anchor fractured bones as they heal. There have been many examples of implant failures, including rupture of silicone breast implants, faulty hip replacement joints and breakable artificial heart valves. The consequences of implant failure depend on the critical nature of the implant and its position in the body. Thus, heart valve failure is likely to threaten the life of the individual, while breast implant or hip joint failure is less likely to be life threatening. The process of implantation of medical devices is subject to the same complications as any other invasive medical procedure, including infection, inflammation and pain. Patients also run the risk of implant rejection if the immune system of the host reacts poorly.