Abstract
Medical devices are any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article intended by the manufacturer to be used, alone or in combination, for a medical purpose. According to their risk, medical devices can be classified as Class I, II, or III. Before devices can be tested and marketed, they must be approved by the US Food and Drug Administration (FDA). The manufacturer can apply for authorization through three different pathways: premarket approval, premarketing notification, and humanitarian device exemption. In making its decision, the FDA considers safety and efficacy data. Even though medical device development is complex and expensive, various funding possibilities are available.