If you’re planning to grow in size, profits, or into new markets, consider expanding to or within the United States.
More than 24,584 domestic (12,848) and foreign (11,736) medical device establishments are registered with FDA.
* Establishment Registration
* Medical Devices Listing
* U.S. Agent Service (Foreign Companies)
* $350.00 USD | Initial Registration Fee
* $300.00 USD | Annual Fee.
Premarket Notification 510(k)
Premarket Approval (PMA)
Owners or operators of companies that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the U.S. FDA (Food and Drug Administration) and list the devices that are made there. This process is known as establishment registration.
Companies required to register their establishments and list their devices with the FDA
* repackage and relabel
* develop specifications
* reprocess single-use devices
* manufacture accessories and components sold directly to the end user.
U. S. Agent service
Medical Device Establishment registration
Medical Device listing
Classification of your medical device to determine the proper FDA product code and regulation number.
Determination of similar (predicate) devices with 510(k) clearance and whether they are suitable for use in your 510(k) submission.
Completion of 21 sections of the 510(k) application.
Payment of 510(k) fees on your behalf (when needed).
Electronic filing of the 510(k) and follow-up with the FDA reviewer.
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