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U.S. Food and Drug Administration
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  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions
  1. How to Study and Market Your Device

Premarket Submissions

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Approvals & Clearances

Resources

Contact FDA

1 (800) 638-2041
(301) 796-7100
[email protected]

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).

Resources

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Device Registration and Listing

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
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Medical Device Databases

Listing of CDRH Databases and their descriptions.

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Contact Us

Contact Point
Division of Industry and Consumer Education
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993

[email protected]

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

Hours Available

Office of Communication and Education

For Updates on Twitter follow

Contact Point Twitter

@FDADeviceInfo

Information and news on device recalls, other safety issues, approvals, and other device and radiation-emitting product topics.


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