How Much Does it Cost to Get a 510(K) Approval?

How Much Does it Cost to Get a 510(K) Approval?

June 15, 2022 By

This blog is meant to be an overview of the average costs associated with bringing a medical device to market under normal circumstances. Depending on when you are reading this blog, the average costs may have changed.

A 510(K) is a premarket submission that is made to the FDA to demonstrate that your medical device can be marketed as safe and effective and that it is substantially equivalent to another legally marketed device. When submitting a 510(K) you must compare your device to one or more legally marketed devices and then make and support your substantial equivalence claims.

The overall cost to get FDA approval for a 510(K) notification ranges between $30,000 and $44,000 USD. This includes the preparation of the submission and all associated FDA costs. The major influencing factors to the final cost are: 1) the cost required to prepare the submission and 2) the qualification of the company as a small business.

The preparation of the submission documents can cost between $20,000 to $25,000 depending on the device’s complexity and adequacy of the provided evidence.

In addition, Congress has authorized FDA to collect an Annual Establishment Registration Fee for devices, of which the FDA charges a fixed cost of $5,672 for Fiscal Year 2022, and this fee is subject to an annual incremental increase. This is for all owners or operations of establishments that are involved in the production and distribution of medical devices in the US. The establishments also need to list all devices and the types of activities performed on those devices. Please note that this establishment is specific to the facility and can contain more than one product.

There is also the Medical Device User Fee that the FDA charges to review the application. This fee ranges from $3,816 (FY2022) for small businesses (certified by the Center for Devices and Radiological Health) to $12,745 (FY2022) for all other types of businesses. Small business is defined as having less than $100 million of gross receipts and sales for the most recent tax year, including its affiliates. The small business certification request needs to be submitted and re-applied for each Fiscal Year (ranging from October 1 to September 30 of the following year).

Should you have questions on how much it takes for your medical device to gain 510K approval or need help applying one, contact us today.

The prices estimated within is document are valid as of June 2022 and are subject to change.