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

FDA Medical Device Establishment Registration and Device Listing Steps by Steps.

Identification of device’s FDA Classification
Obtaining company and device info and DUNS request submission

FDA payment account creation and annual user fee payment

Medical device establishment registration and device listing
Registration approved by FDA and certificate issued by
Metti FDA Consultings

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 5,546 USD for the year 2021. 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 an official correspondent, or U.S. agent, as FDA’s primary point of contact before importing into the United States.

Importance of U.S. FDA Agent

The U.S. agent may be called upon to speak with FDA in regard 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, Metti FDA Consultant LLC 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, distributors and other commercial outlets.

Service & Fees:

  • Initial Assessment Determining if FDA Registration Necessary, 100 USD
  • Registration of Device Establishment, 695 USD
  • Annual FDA fee payment on your behalf, 50 USD
  •  Listing of Medical Devices, 195 USD/ 4 Device Class
  • Act as Official Correspondent (U.S. Agent) to FDA, 50 USD
  • Certificate of FDA Registration and Device Listing, 50 USD
  • Registration Verification and Interim Updates, 50 USD
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