What is a medical device?
According to the Federal Food, Drug and Cosmetics Act a medical device is defined as “… a product intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease… and which does not achieve its primary intended purpose through chemical action within or on the body… and which is not dependent on being metabolised for the achievement of its primary intended purposes.”
This ten minute video from the FDA (Food and Drug Administration) explains the processes by which a medical device comes to market. Devices must pass through several stages before this can happen. Beginning with an idea and a design, the device moves from a prototype developed and tested in a laboratory setting into something that can be assesed in human clinical trials and finally, if all goes well, the device will be awarded a license and may be sold on the US medical devices market.
- FDA’s page on Medical Devices