The small-business rate isn't retroactive

FDA Radar doesn’t read fee schedules. No submission fee has ever generated an item in its corpus, and none ever will — a fee isn’t a Federal Register notice, a warning letter, a recall, or a clearance. But almost everyone this pipeline is built for signs a fee cover sheet at some point, and the small-business rate on that cover sheet gets treated, in practice, like a checkbox. It isn’t one. It’s a determination with its own clock, and the clock can run out before the submission does.

Three thresholds, one statute

Section 738 of the FD&C Act (21 U.S.C. § 379j) sets the medical device user fee framework, and FDA’s small-business program under it runs three separate gross-receipts tests, not one. A firm — counting every U.S. and foreign affiliate together — with gross sales or receipts of $100 million or less qualifies for a reduced fee on most submission types: for fiscal year 2026, a $26,067 standard 510(k) fee drops to $6,517, a 75 percent cut. At $30 million or less, a firm gets the fee waived entirely on its first PMA, PDP, PMR, or BLA. At $1 million or less, and only after showing the annual registration fee itself would be a financial hardship — a new, discretionary test FDA added for FY2026, not an automatic pass — a firm can have that fee waived too. Three tiers, three different qualifying tests, and none of them apply until FDA says they do.

The determination has its own calendar

Qualifying isn’t automatic and isn’t permanent. A firm has to file a Small Business Determination request — complete, signed federal tax returns for the firm and every U.S. affiliate, a National Taxing Authority certification for each foreign one — and FDA has 60 calendar days to decide it. The determination is good for exactly one fiscal year, October 1 through September 30, and expires with it: there is no multi-year status, only an annual one, requalified from scratch every cycle. For FY2026, FDA moved the filing deadline for staying current to July 31 — sixty days ahead of the fiscal year it covers — and registration-fee-waiver requests run on their own separate window, August 1 through October 31.

The small-business rate isn’t a fact about a company. It’s a decision FDA makes, on a schedule FDA sets, and it doesn’t reach backward to cover a submission filed before the decision existed.

The practice

Submit a 510(k) or PMA before FDA has issued the Small Business Decision number, and the standard fee is owed for that submission, full stop. FDA does not refund the difference if the determination clears afterward, even by a day. The operational fix is sequencing: treat the SBD request as the first item on a submission timeline, not a line item to sort out once the technical file is done, and re-check it after anything that changes the gross-receipts picture — a funding round, an acquired affiliate, a foreign parent’s first U.S. filing. Whether a specific company’s structure actually clears any of the three thresholds is a determination for whoever prepares that firm’s MDUFA submissions, not a field this pipeline, or this post, can fill in. This is regulatory intelligence about how the fee mechanism is timed, never regulatory advice about a specific filing.