FDA Update

FDA to Grant a Registration Fee Waiver if Financial Hardship is Proven

The FDA again – Gives it and then Takes it Away.

Originally, it looked good for a 2026 small business FDA registration fee.  Supposedly, small business could be exempted from the Annual Registration fee which will rise to over $11,000 in 2026.

The FDA posted that for fiscal year 2026, they may, but are not required to, grant a waiver of the fee for annual registration to applicants that qualify as a small business and if FDA finds that the establishment is a small business, and that company that had paid the fee for such year represents a financial hardship to the establishment as determined by FDA.

FDA intends to grant waivers only where financial hardship is shown by a clear and objective standard, the meeting of which is publicly transparent.

The only situation FDA is currently aware of that meets the above description is where the small business is in active bankruptcy. The FDA believes that active bankruptcy represents financial hardship that is shown by a clear, objective standard, the meeting of which is a matter of public record.”

So, basically, if you are a small business and paying the new FDA user fee of $11,423, could be a financial burden for you, sorry, you do not quality unless you are in bankruptcy.  Boy, when it was first proposed by the FDA, it sure looked good.

Any Questions email us?

For more information on the FDA process for a registration fee waiver please email us at: info@mdiconsultants.com and ref: FDA process for a registration fee waiver