Laboratory Information:
Center for Devices and Radiological Health
10903 New Hampshire Avenue
WO66-4303
Silver Spring, MD 20993
Website: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/default.htm
Technology Transfer Website: http://www.fda.gov/AboutFDA/business/ucm119486.htm
Agency/Department: Dept. of Health and Human Services
Region: Mid-Atlantic
FLC Laboratory Representative:
Dr. Michelle Chenault
Phone: (301) 796-5679
Fax: (301) 847-8509
Email: v.chenault@fda.hhs.gov
Background/History of the Laboratory:
FDA's Center
for Devices and Radiological Health is responsible for
ensuring the safety and effectiveness of medical devices and
eliminating unnecessary human exposure to man-made radiation
from medical, occupational and consumer products. There are
thousands of types of medical devices, from heart pacemakers
to contact lenses. Radiation-emitting products regulated by
FDA include microwave ovens, video display terminals, and
medical ultrasound and x-ray machines.
Mission of the Laboratory:
The center
accomplishes its mission by reviewing requests to research or
market medical devices; collecting, analyzing, and acting on
information about injuries and other experiences in the use
of medical devices and radiation-emitting electronic
products; setting and enforcing good manufacturing practice
regulations and performance standards for radiation-emitting
electronic products and medical devices; monitoring
compliance and surveillance programs for medical devices and
radiation-emitting electronic products providing technical
and other nonfinancial assistance to small manufacturers of
medical devices.
Facilities:
Technology Transfer Mechanisms:
- Cooperative Research and Development Agreements (CRADAs)
- Patents and Licensing
- Technical Assistance
Technology Areas of Expertise:
- Food consumption limiting devices
- Glucose monitors
- Home health care.
- Human genome project
- Nanotechnology
- Pacemakers
- Prosthetics
- Endoscope camera alternatives
