Medical Devices

Products and Medical Procedures

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.

Contact FDA

1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Industry and Consumer Education (DICE)(formerly DSMICA)

Office of Communication and Education

Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

WO66-4621

Silver Spring, MD 20993

Page Last Updated: 06/04/2014
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