Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers.
Recalls & Alerts
Tools & Resources
CDRH-Division of Industry and Consumer Education (DICE)
Office of Communication and Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire AvenueSilver Spring, MD 20993