FDA 510(k) Device Fee 2027: Cost for Instrument Buyers

The FY2027 FDA 510(k) fee strengthens the advantage of established instrument suppliers: a standard filing plus one fee-paying establishment reaches $42,438 before testing, consulting, or submission preparation. The total combines a $28,653 standard 510(k) fee with the separate $13,785 annual establishment-registration fee. A qualified small business can reduce the filing portion to $7,163, but FDA approval is required first. For hospital buyers, the likely result is fewer small workshops attempting a new U.S. entry and more of the same incumbent forceps, clamps, hemostats, and retractors in 2027 catalogs—not a new wave of competitors pushing prices down (FDA fee schedule).

FDA fiscal year 2027 runs from October 1, 2026, through September 30, 2027. FDA published the rate notice on July 30, 2026 (Federal Register notice). The fees are real and current; the prediction about catalog competition is an economic inference. FDA has not published a figure showing how many instrument workshops will decline U.S. entry because of these rates.

The Routine-Fee View Is Right for Large Product Lines

The usual industry view is that annual MDUFA adjustments are administrative costs that manufacturers absorb. That is fair for a high-volume supplier able to spread a filing fee across years of sales and many units. A $28,653 charge can become a small per-unit amount when the addressable product line is large enough.

The consensus is also right that a user-fee increase does not automatically remove a device from a catalog or dictate its selling price. Testing requirements, predicate strategy, distribution, quality-system costs, demand, and the manufacturer’s existing U.S. operations can matter more than the filing fee.

The view breaks down at the edge of the market. A domestic machine shop developing one instrument line, or a small overseas maker seeking its first U.S. distributor, encounters the fee as a fixed cash gate. At the standard tier, one 510(k) and one registration charge total $42,438. Even with approved small-business status, the same illustration totals $20,948. Those amounts buy neither testing nor guaranteed clearance.

That distinction matters to procurement. An incumbent can keep offering established product lines while evaluating new submissions selectively. A new entrant must decide whether expected U.S. margin justifies the regulatory fixed cost before buyers ever see a sample, quote, or catalog listing.

Enter a line’s expected revenue, volume, and wholesale margin; the calculator shows whether the entrant or incumbent has the cost advantage.

The calculator’s defaults are a planning scenario, not market data. The supplied FDA material does not establish a typical workshop’s annual line revenue, unit volume, or forceps wholesale margin. Replace those assumptions with a supplier’s forecast when evaluating a proposed line.

What the FY2027 Fees Actually Buy

The 510(k) user fee pays for FDA review of a fee-paying premarket notification. It applies to the submission; it does not purchase clearance, testing, consulting, technical writing, or a favorable substantial-equivalence decision.

The FY2027 charges are:

The last row is an illustration, not a universal invoice. Registration obligations depend on the establishments and activities involved. An applicant may not owe a registration fee at its own level, while a supply arrangement involving multiple fee-paying establishments may produce more than one registration charge.

Registration, listing, and premarket review remain separate concepts. Paying the 510(k) fee does not register an establishment or list a device. Paying the establishment fee does not clear a device or complete the associated regulatory work.

The establishment fee is also not reduced by the ordinary small-business application rate. FDA describes a narrower discretionary financial-hardship waiver for certain qualified small businesses, but it excludes initial registration and should not be treated as a standard registration discount.

Small-Business Status Cuts the Filing Fee but Is Not Automatic

The difference between the two 510(k) tiers is substantial:

$28,653 − $7,163 = $21,490.

A business may generally qualify for reduced medical-device application fees when combined gross sales or receipts for the applicant and all affiliates are no more than $100 million. Meeting that threshold does not itself authorize the $7,163 payment. The applicant must obtain an approved FY2027 CDRH Small Business Determination before using the reduced rate (FDA Small Business Determination Program).

The determination is tied to the approved legal entity and fiscal year. It is not transferable to a parent, subsidiary, sister company, distributor, consultant, or another applicant. Approval from an earlier fiscal year should not be treated as FY2027 approval.

FDA opened the FY2027 Small Business Request window on August 1, 2026, at 4:01 p.m. Eastern Time. Requests are submitted electronically through the CDRH Portal, and FDA does not charge a fee for the request. The supplied evidence does not establish one document list or approval time for every applicant.

This process is particularly relevant to overseas instrument makers. A workshop may be small in ordinary commercial terms but still lack an approved FDA determination for the correct applicant entity. Unless it completes the qualification process, it cannot budget the reduced rate merely by asserting that its revenue is below the threshold.

FDA’s first-application waiver does not solve that issue for a 510(k). The waiver concerns specified submissions such as PMAs, BLAs, PDPs, or PMRs—not a company’s first 510(k).

The Fee Increase Falls Hardest on Low-Volume Lines

Both 510(k) tiers rise by approximately 9.9% from FY2026 to FY2027.

The percentage is not a separate surcharge. It is the calculated change between FDA’s published dollar amounts.

For procurement, the absolute fee and expected unit volume are more informative than the percentage increase. At 3,000 units, the illustrative $42,438 standard-fee total allocates about $14.15 per unit before any testing or consulting expense. At the qualified-small-business total of $20,948, it allocates about $6.98 per unit.

Those are arithmetic illustrations, not estimates of a manufacturer’s complete regulatory cost. The fee can be spread more thinly if volume is higher or recovered over multiple years. It becomes harder to justify when the U.S. opportunity is one specialized jaw pattern, length, or handle variation with modest demand.

This is where the catalog effect is most plausible. The fees are unlikely to erase established, high-volume hemostat or forceps lines by themselves. They are more likely to discourage a marginal new entrant or a narrowly differentiated product whose expected margin does not comfortably exceed the fixed regulatory gate.

The Registration Charge Persists Beyond the Filing Decision

The $13,785 annual establishment-registration fee is owed separately by each establishment required to register and pay. It is annual rather than a one-time 510(k) review charge.

A manufacturer should not automatically attach exactly one registration fee to every submission. The applicant, contract manufacturer, specification developer, foreign establishment, and other parties can have different obligations depending on the arrangement. That mapping requires device- and entity-specific regulatory analysis.

For a buyer assessing whether a proposed supplier is commercially ready, the useful distinction is simpler: a quoted 510(k) fee is not necessarily the supplier’s complete FDA-fee exposure. Registration may add $13,785 for each applicable fee-paying establishment, and listing or administrative work remains separate.

Third-Party Review Can Remove the FDA Filing Fee, Not the Project Cost

Traditional, Abbreviated, and Special 510(k) submissions are generally subject to the user fee. An eligible 510(k) submitted through an FDA-accredited third-party reviewer carries no FDA 510(k) user fee (FY2027 pathway summary).

That does not make review free. The accredited reviewer may charge its own service fee, and the applicant still bears applicable development, testing, registration, listing, and submission-preparation expenses. Eligibility is not universal, and the supplied evidence does not provide a typical third-party price or prove that this route is cheaper or faster for a particular instrument.

The exception therefore weakens, but does not eliminate, the fixed-cost argument. A workshop with an eligible device should compare a written third-party quote against the FDA fee rather than assume either route wins.

Devices Outside the 510(k) Path Face a Much Higher Fee

The analysis here is scoped to devices eligible for a 510(k). It should not be read as a claim that every forceps, clamp, retractor, or related product requires that pathway.

For a device requiring a PMA instead, the FY2027 standard fee is $636,732, and the small-business PMA fee is $159,183, according to FDA’s fee schedule. Classification and pathway decisions therefore precede fee budgeting; a manufacturer cannot choose the 510(k) price simply because it is lower.

October 1 Can Change the Applicable Rate

FY2026 ends September 30, 2026, and FY2027 starts October 1. The standard 510(k) rate rises by $2,586 at that boundary, while the approved-small-business rate rises by $646.

Sending or initiating payment before October 1 should not be assumed to lock in an FY2026 rate. Payment initiation, Treasury recognition, submission transmission, and FDA receipt can occur at different times. Secondary explanations do not describe the controlling event consistently enough to support a universal cutoff rule.

Manufacturers filing near the boundary should verify FDA’s current payment and receipt instructions, allow processing time, retain payment records, and recheck the amount before submission. The Federal Register entry is document 2026-15335, cited at 91 FR 48134, under Docket No. FDA-2026-N-7492, covering pages 48134–48142. Its notice page links to the official GovInfo PDF and cautions that the FederalRegister.gov XML is an unofficial informational rendition (notice record).

MDUFA V remains in effect through September 30, 2027. The FY2027 rates and policies should not be assumed to continue under a later authorization.

What Buyers Should Expect in 2027 Catalogs

The defensible procurement forecast is narrower than saying fees alone determine the market. Large suppliers can amortize the charge, qualified small businesses can save $21,490 on a filing, and eligible devices may use accredited third-party review without an FDA 510(k) user fee.

But the fixed gate remains meaningful for a low-volume workshop. The standard-rate illustration reaches $42,438 before the broader work needed to prepare and support a submission. That favors suppliers already selling into the United States and makes a speculative new instrument line less attractive.

Buyers should therefore expect continuity to be more common than disruption: familiar incumbent lines, selective additions, and fewer marginal entrants able to justify a U.S. filing. The available evidence does not quantify how many products will be withheld or prove that incumbent prices will rise. It does show why the FY2027 fee update is more than an administrative footnote for a small workshop—and why procurement teams should ask whether a promised new line has a funded U.S. regulatory path before building it into next year’s sourcing plan.