22.5.1 Medical Device Studies (Investigational Device Studies)
There are many different types and intended uses of medical devices. Medical devices are implants (i. e., pacemaker), devices to monitor a user (i. e., blood pressure cuff), devices to sustain human life (i. e., ventilator) or devices important in diagnosing, curing, or treating a disease. Other medical devices are, for example, disposable contact lenses or wound dressings. An investigational device is a medical device which is the subject of a clinical trial in order to evaluate the effectiveness and/or safety of the device. Like the pharmaceutical studies, these studies require a research protocol, approval through the IRB ethics committee, and signing an informed consent form. Subjects will usually have to come in more than once for a follow-up visit, just like in pharmaceutical studies.