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.
Recalls & Alerts
Contact Us
- 1-800-638-2041
- 301-847-8149 (Fax)
- dsmica@fda.hhs.gov
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4613
Silver Spring, MD 20993