FDA 510K Costs

510K Costs and 510K Fees

How Much Does a FDA 510k Approval Cost?

What is the FDA 510 K Program?

The FDA 510k pre-market notification program was created to systematically process, approve, and import new medical devices, dental devices, and other medical products into the United States. The FDA 510 K program gives medical and dental manufacturers from other countries the opportunity to mass market their new products, devices, and instruments legally within the United States.

FDA 510K Costs and Fees

The vast majority of our FDA 510K clients generally spend upwards of $20,000-$30,000 just 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 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.

FDA 510K Costs-

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

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

Our FDA 510K services fee includes-  proper preparation of your 510k pre-market notification, assistance with new product testing, along with working with you and your FDA reviewer through the entire FDA 510k clearance and approval processes.

510k Device Review User Fee – $2,614 or $5,228

The FDA charges to review the entire 510k application, the product, and the business that is applying for the FDA 510k clearance approval. There are two rates for the device review; $2,614 for any business that sells less than $100 million in annual sales, and $5,228 for any business that sells more than $100 million in annual sales. 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 ascending country’s governing tax authority. Our professional FDA 510 K consultants can also help you with filing this paperwork along with the FDA 510K petition.

Establishment FDA 510 k Registration Fee – $3,845

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

FDA 510K Device Listing – No charge by FDA

 

FDA 510 K Guidance And Tips-

If you have never registered a new device or product with the FDA, you will have to wait for the 510(k) clearance is received before you can file the “Establishment FDA 510 k Registration Fee payment”. This FDA 510k fee must be paid within 30 days of receiving clearance from the FDA. 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 any and all companies. 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 has to have a FDA 510K  approval.  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 510k 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.

After your device has received the final FDA 510K clearance and approval, your newly approved device goes into the FDA device listings database as a FDA approved 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 510K Fees Schedule
For our international clients, we offer a service to be your U.S. Agent.  We will provide you the duties and services to represent you as your Agent and answer and questions regarding your shipments into the U.S. for custom 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 510 K Consulting Services

Contact 510KFDA.com today for more information on our FDA 510K services