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  1. How to Study and Market Your Device

Premarket Submissions

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Approvals & Clearances


Contact FDA

1 (800) 638-2041
(301) 796-7100

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

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Medical Device User Fees

Federal law authorizes FDA to charge a fee for medical device product review. These fees apply to Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), Premarket Reports (PMRs), Panel-Track Supplements, Efficacy Supplements, 180-day Supplements, Real-Time Supplements, 30-Day Notices/135-Day Supplements, Biologics Licensing Applications (BLAs for certain medical devices reviewed by FDA's Center for Biologics Evaluation and Research), and Requests for Information (513(g)s).