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  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  1. How to Study and Market Your Device

Premarket Submissions: Selecting and Preparing the Correct Submission

How to Study and Market Your Device outlines four steps for bringing a medical device to market in the United States. This section is designed to assist you with: 


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TYPES OF PREMARKET SUBMISSIONS

Premarket Notification 510(k)

For Class I and II devices that are not exempt from premarket review or are not subject to another type of marketing submission.

SUPPORT FOR PREMARKET SUBMISSIONS

Device Master Files

CDRH Device Master Files (MAFs) are voluntary submissions of confidential information to the Agency.

PREPARING, SENDING, AND TRACKING SUBMISSIONS

USER FEES

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Contact Point
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center (DCC) – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

301-796-6250

Hours Available

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


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