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U.S. FDA Medical Devices Registration and FDA Device Listing

 U.S. FDA Medical Devices Establishment Registration and Device Listing


According to U.S. FDA medical device regulations all medical device establishments that develop, manufacture, pack, assemble, label, export or import medical devices are required to Register with FDA (FDA Device Establishment Registration) and pay an annual FDA user fee  that is 7,653 USD for the year 2024. The registered medical device establishment must also list all of their medical devices individually (FDA Device Listing) prior to commercial distribution in the U.S. market. Aside from device establishment registration and device listing, all medical device firms that are located outside U.S. are required to appoint a official correspondent, or U.S. agent, as FDA's primary point of contact before importing into the United States.

Related Article: Who Must Register and Pay the FDA Fee.

Importance of U.S. FDA Agent

The U.S. agent may be called upon to speak with FDA in regards to the foreign registered facility. This can be a time-sensitive matter. As a result, it is crucial that the U.S. agent understands the FDA regulations and is able to advise the foreign establishment on FDA medical device requirements that must be followed. Furthermore, having an independent U.S. agent will prevent a potential conflict of interest that can appear when assigning a business partner as U.S. Agent.

FDA Listing Inc. provides FDA medical devices establishment registration and medical device Listing and can act as U.S. FDA Agent to Non-US companies that are already in the market or intending to enter the U.S. market. Click the front start button for medical devices establishment registration and device listing.

FDA Registration Certificate

After your registration is complete, the registered medical device establishment will be allocated with a FDA registration number from FDA. The FDA registration number will identify your company with FDA as well as assist you in the custom clearance process. U.S. FDA does not issue any registration certificate however, as a third party firm, FDA Listing Inc. will provide you with a certificate of FDA registration that can be used as FDA registration confirmation. The FDA registration certificate is good for one year and the copy of the FDA registration certificate can be used as a proof of registration before U.S. custom, importers, distributers and other commercial outlets.


To request a quote about "U.S. FDA Medical Devices Registration and FDA Device Listing" submit US FDA Registration Help form or call us at +1 929-376-7870 to speak with one of our agents for help.

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Contact Info:
Address:82 Nassau St,New York,NY 10038,USA
Phone: +1 929-376-7870

 Service & Fees: 

  • Initial Assessment Determining if FDA Registration Necessary, Free
  • Registration of Device Establishment, 545 USD
  • Annual FDA fee payment on your behalf, Free
  •   Listing of Medical Devices, 95 USD/ 4 Device Class
  • Act as Official Correspondent (U.S. Agent) to FDA, Free
  • Certificate of FDA Registration and Device Listing, Free
  • Registration Verification and Interim Updates, Free Inc., referred as FDA Listing Inc., is a privately held regulatory assistance company with headquarters in New York, USA. FDA Listing Inc. has no affiliation with or endorsement by United States Food and Drug Administration. The certificates issued by FDA Listing Inc. are only for the sake of confirmation of FDA registration for your industry partners and are not recognized by United States Food and Drug Administration - FDA.

U.S. FDA Registration and Listing Inc

82 Nassau St, New York,
NY 10038, USA
Phone: +1 929-376-7870
Email: info