FDA 510K Costs

FDA Costs and Consulting Service Fees

How Much Does a FDA 510k Approval Cost?

The vast majority of our FDA 510K clients generally spend in the range of $20,000-$30,000 to have their product or device prepared and reviewed before the actual FDA 510k submission process. This average pricing model is based on the fact that the pending product has a already been approved in another major country that has a governing regulating body that approves or denies new medical devices. If a new product or device does not have any approvals in any country, the cost of the FDA 510k approval process will increase substantially as the manufacturer will now have to conduct numerous new product tests for usage, performance, safety, sterilization, bio-compatibility, electrical, and technical.

As most of the testing of a new product is normally conducted by a third party service, the performance and technical testing is traditionally completed by the actual manufacturer. One of the positive sides to seeking a FDA 510K approval for a new medical product, whether tested or untested, is that if there is already a similar FDA approved product being marketed, then the FDA will have to approve any new products that are almost the same as the product that is already FDA 510 K approved and have under gone all required testing, documentation, and registration processes.

Listed below are the FDA 510K costs and our consulting fees. Please keep in mind that these prices reflect only the FDA 510K registration and approval processes. These prices do not include any amounts that would be incurred from 3rd party testing facilities.

FDA 510k Regulatory Consulting Service – Contact Us for a Quote

Our FDA 510(k) consulting fee includes proper preparation of your 510k pre-market notification, assistance with new product testing, working with you and your FDA reviewer through the entire FDA 510(k) clearance and approval processes.   Our fee for this service ranges from $12,000 - $20,000, depending on complexity and existing device documentation.

FDA 510(k) Device Review User Fee – $4,967 or $19,870 (2023)

The FDA charges to review the entire 510(k) application, the product, and the business that is applying for the FDA 510(k) clearance approval. There are two rates for the device review; $4,967 for any small business that sold less than $100 million in the last tax year, and $19,870 for any business that sells more than $100 million in the last tax year. Before filing your FDA 510(k) petition, you will need to have proper documentation confirming  your business status as a small or large scale business. This paperwork is usually issued by the IRS or your country’s governing tax authority. Our professional FDA 510(k) consultants can help you with filing this paperwork before the FDA 510(k) petition.

FDA Annual Establishment Registration Fee – $6,493 (2023)

The FDA charges a flat registration fee for for all businesses interested in manufacturing or marketing their products and devices in the United States. If your company is already registered with the FDA, then there is no additional charge.

If you have never registered a device or product with the FDA, you will have to pay the “Annual Establishment Registration Fee”.  Companies that already have products registered with the FDA do not have to pay the Establishment Registration Fee for any new device they plan on selling n the United States. One Establishment Registration covers all devices and products listed by a company. Unfortunately, the Establishment Registration Fee has to be paid each and every year to the FDA.  These payments are accepted no earlier than October 1st and no later than Dec. 31st for any and all companies that want to be able to sell their medical devices and products within the United States.
All foreign or domestic businesses that develop, manufacture, re-brand, or import any type of medical device for distribution in the United States must register as an establishment.  Any and all manufacturers, distributors, exporters, or resellers from any other country other than the U.S. will have to hire a professional U.S.   Agent to represent the foreign company. For example- A manufacturer in Germany creates a dental xray machine and wants to use a US distributor to sell their product line exclusively. In order for the manufacturer to sell their equipment and devices in the US, both the manufacturer and the US distributor have to register with the FDA and pay the annual Establishment Registration Fees.

FDA 510(k) Device Listing Service

After your device has received the final FDA 510(k) clearance and approval, your newly approved device goes into the FDA device listings database as a FDA-registered device. The FDA Device Listing process is also an annual event that happens along with the yearly Establishment Registration Fee payment. The Device Listing process is completed by the FDA at no additional charge to the annual Establishment Registration Fee payment.

FDA 510(k) US Agent Service

For our international clients, we offer a service to be your U.S. Agent.  We will represent you and answer any questions from FDA regarding your shipments into the U.S. for customs purposes.  This service also includes assisting you with the Establishment Registration and the listing of your new device.  If you are interested there is additional information on this service and a form to fill out that you can send to us.  Let us know if you have any questions regarding this service.

FDA Certificate to Foreign Governments(CFG)

A CFG is required by many medical device market regulators in order to legally sell your device in their territory.  A CFG confirms that your device has been registered for sale in the US.   We can obtain a CFG from the US FDA on your behalf.

FDA 510(k) Consulting Services

Our consulting service retainer includes 4 hours of expert research and advisory services: