If your product is labeled or used in a manner that meets this definition it will be regulated as a medical device and is subject to FDA’s laws and regulations before, during, and after it is offered for sale or use in the United States. View examples of medical devices.
Additionally, the Federal Food, Drug, and Cosmetic Act (the Act) provides a means for obtaining the FDA’s views about the classification and the regulatory requirements that may be applicable to your particular device.
