Did you know that the FDA has two types of fees for those companies that want to apply to a 510k? One called “Standard fee” and the other “Small Business 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, 2023 is $19,870.00; and the small business fee is US$ 4,967.00.
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:
Here’s a simple explanation of what a pre-marketing submission (510k) request for your medical device is
A quick and accurate look at how long your 510k application may take once it is received by the FDA for review.