The FDA considers a product to be a device, and subject to FDA regulation, if it meets the definition of a medical device under Section 201(h) of the Food, Drug, and Cosmetic Act. These panels broadly cover medical specialties, such as cardiovascular, immunological or physical medicine. In addition, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits and blood glucose meters. Due to their generally low-risk nature, they do not need to be classified and regulated as a medical device under the FDA.
Medical devices can range from simple contact lenses to knee prosthesis implants and medical devices with embedded software, such as pacemakers. It is not used as a diagnostic procedure without the diagnosis being confirmed by another medically established diagnostic product or procedure. Once you have defined the intended use and indications for use of your product, you can determine whether the product meets the definition of a medical device. Like drugs, medical devices in the United States undergo a review process by the US Food and Drug Administration (FDA) before they can be marketed for use in patients.
The moderate risk posed by Class II medical devices requires what are known as "special controls, as general controls alone are not sufficient". Class I medical devices are those with the fewest regulatory controls and minimal potential harm to the patient. Some electronic products that emit radiation and have a medical use or make medical claims are also considered medical devices. At this stage, many innovators partner with medical device companies, which conduct a detailed market analysis to determine which devices to support.
To determine whether your product meets the definition of a medical device, you must define the intended use and indications for use of your product. The Centre for Devices and Radiological Health (CDRH) is the specific branch for medical devices.