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All medical device establishments must meet certain requirements for their devices. These entities are involved in producing and distributing medical devices that will participate in commercial distribution within the United States. That also includes what will be imported only. All must register with the FDA. Some common questions when it comes to FDA medical device registration are:

  • How do you update information for the owner or official correspondent? Information regarding the operator can be created and updated in the Account Managemengement module of FURLS, which can be accessed by logging into the FDA Industry Systems. Once you enter the information, it will be automatically transferred to the Device Registration Listing Module (DRLM) records. 
  • Do in-house brands, and private labels need to include proprietary names on each private-label device? Yes, all FDA device registration device listings should include up-to-date proprietary names used to market devices made in the United States. 
  • Is the Medical Device Excise Tax included with the Annual Registration User Fees? No, they are not included since it is not related to changes in registration and listing requirements, nor is it enforced by the FDA.
  • Can an individual represent foreign establishments as their U.S. or as their official correspondent? Yes, but you must live in or have business in the United States. Post office, lock, and mail service drop boxes do not count.

UReg FDA registrations can answer these questions and many more for your business. We are here to make the process of registering and complying with FDA rules and regulations for FDA device registration more simple. Call us at 786.442.2543 or visit us online for more information. 

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