Medical practices within the United States that purchase devices for use within their offices do not need to register said devices, as the registration of devices is only required of "establishments that are involved in the production and distribution of medical devices intended for commercial distribution," as reported by the U.S. Food and Drug Administration. Examples of establishments that need to register devices include contract manufacturers, contract sterilizers, initial importers, manufacturers of accessories or components of medical devices, manufacturers of custom devices and relabelers or repackagers.Continue Reading
There are many different forms and codes of federal regulations provided by the FDA that must be addressed by those required to register medical devices. The full listing of documents can be found on the FDA website and on the Emergo Group website. Before medical devices can be registered with the FDA or used within the medical community, they must also go through a difficult and exhaustive application process.
Medical devices are an important part of the medical landscape as they provide new ways for doctors to test for and treat illnesses, injuries and diseases. These devices are able to offer patients a higher quality of life in addition to a longer life when compared to patients a few decades ago. It is currently estimated that the United States spends $95 to $150 billion dollars on medical devices each year.Learn more about Managing a Business