510k Payment fee

Each time a company submits an application to be reviewed by the FDA (510k, 513g, PMA, PDP, PMR, BLA, De Novo, etc.) they must pay a fee.

These fees were first established in 2002 through the Medical Device User FEEs and Modernization Act (MDUFMA), in order to help increase the efficiency of the regulatory processes and reduce the time it takes to bring safe and effective medical devices to the U.S. market. Rates are subject to a slight increase each new fiscal year, which, for this purpose, begins on the first day of October.

However, the FDA has a rate reduction program aimed at small businesses wishing to apply for a 510k. A small business is considered one that can provide a turnover of less than US$100 million per year.

The full standard fee for a 510k effective September 30, 2024 is $21,760.00; and the small business fee is US$ 5,440.00.

The application process is relatively simple, but it takes some time. At Compliance 4 Devices we advise our clients, help them fill out the form, and send the documents by express mail to the FDA. This approval process can take up to 60 days, which is why, in most cases, we suggest that our clients start with this procedure as soon they decide to pursue the 510K with us. This will allow you to move forward with all the processes in parallel, ultimately saving time.

There are two important aspects to this:

1. The company must attach its most recent tax return to the application, which must be certified and/or validated by the tax office of the country of origin.
2. Small business certificates always expire on September 30 of each year; as a result, in some very specific cases it is advisable to delay the application to be incorporated in the next period that begins in October of each year.