The FDA regulates medical devices sold in the United States to assure their safety and effectiveness.
Medical devices range from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. Our Medical Device Product Classification database lists over 6,000 types of medical devices regulated by FDA's Center for Medical Devices and Radiological Health (CDRH) and the classification assigned to each type.
Depending on the device classification, along with other factors, federal regulations (such as the Code of Federal Regulations, Title 21) define requirements that must be fulfilled for CDRH to approve or clear devices sold in the United States.
Devices used by health care professionals to support patient care, such as hospital beds, infusion pumps, medical device connectors, medical device data systems (MDDS), and sterilization systems (liquid chemical, ethylene oxide).
Devices that consumers use themselves, such as bed rails, breast pumps, contact lenses, hearing aids, sharps (needles and syringes), electronic muscle stimulators, and artificial pancreas device systems.
Devices or tissues that are placed inside or on the surface of the body, including breast implants, cochlear implants, mesh implants, phakic intraocular lenses, and cerebral spinal fluid (CSF) shunt systems.
Tests done on samples such as blood or tissue that have been taken from the human body, such as blood glucose monitoring devices, direct-to-consumer tests, drugs of abuse tests, home use tests, laboratory developed tests, nucleic acid based tests, and warfarin INR test meters.