FDA Device User Fee & 510(k) Timeline Calculator (FY 2027)

How much will FDA charge?

FDA user fees for FY 2027, from FDA's MDUFA fee page [1].

Submission Company size (gross receipts or sales, including affiliates, most recent tax year)

No Small Business Determination (SBD) — standard fee FDA-qualified small business: $100 million or less [2] FDA-qualified small business: $30 million or less, and no first PMA/PDP/PMR/BLA submitted before by you or any affiliate [2]

The 510(k) goes to FDA through an FDA-accredited third-party reviewer Add the annual establishment registration fee

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510(k): what happens by when?

FDA's MDUFA V goals for 510(k)s [3] and the 180-day limit for answering an Additional Information (AI) request [4]. These are FDA goals, not guarantees.

Date FDA received your 510(k) Days your 510(k) has been on hold so far (waiting for your answers) Date of FDA's AI request (if you got one)

What is an "FDA Day"?

FDA counts the 90-day 510(k) goal in "FDA Days": calendar days when the submission is under review at FDA. While FDA waits for your answers (a hold, such as an AI request), those days don't count. That is why "90 days" often takes much longer on the calendar [3].

Establishment registration: key dates

From 21 CFR 807.22 [5].

Date you started an operation that needs registration (optional) Date your registration information changed (optional)

Quick answers

Does a small business pay less for annual registration?

No. The reduced small business fees apply to applications and reports, not to the annual establishment registration fee. FDA may waive the registration fee only for firms with $1 million or less in gross receipts or sales that show financial hardship and have paid the registration fee in a prior year — so never for the initial registration [1] [2].

Does the $30 million "first application" waiver cover a 510(k)?

No. It covers only a firm's first PMA, PMR, PDP or BLA. A 510(k) from a small business pays the reduced small business fee [2].

Is there a fee for a 510(k) sent through a third-party reviewer?

There is no FDA user fee for a 510(k) submitted to FDA on behalf of an FDA-accredited third-party reviewer. The third party charges its own fee [1].

When do the fees change?

Every October 1, the start of the U.S. federal fiscal year. The FY 2027 rates were announced in the Federal Register on July 30, 2026 [6].