Most medical device inventions start out as a single great idea, but how does that idea become a marketed medical device? This video provides a brief overview of how a medical device, which can range from a contact lens to a knee implant to an MRI machine, begins with an idea and ends with its submission to FDA. The video highlights aspects of the Investigational Device Exemption (or IDE) process, and provides general information on medical device clinical trials. The audience is device manufacturers and health care professionals.
Presenter: Chrissy Cochran, PhD Toxicologist, FDA
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A medical device (biomedical/medical equipment) is an instrument, apparatus, implant, in vitro...