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  1. Device Advice: Comprehensive Regulatory Assistance

Premarket Submissions

Premarket Submissions

Cross Cutting

Approvals & Clearances

Resources

Contact FDA

1 (800) 638-2041
(301) 796-7100
DICE@fda.hhs.gov

Information-Medical Devices / Radiation Products
Division of Industry and Consumer Education
CDRH-Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993