A small-business determination counts every affiliate

This blog has already covered how MDUFA's 90-day interactive-review figure is a performance goal FDA reports against, not a deadline a sponsor can enforce. The same user-fee statute runs a second, entirely separate program most first-time sponsors only discover when a submission fee comes due: a reduced or waived fee for a business FDA determines is small enough to qualify. The qualifying test isn't a look at the applicant's own bank balance. It's a control test that reaches out to every affiliate the business has, anywhere in the world, and adds their gross receipts to the applicant's own before anything gets compared to a threshold — which is exactly the part of the program that catches sponsors who assumed only their own numbers counted.

Three thresholds, three different benefits

The Small Business Determination program isn't one badge that unlocks everything at once. A business, including its affiliates, with gross sales or receipts of $100 million or less for its most recent tax year qualifies for a reduced fee — standard practice sets that reduction at half the ordinary rate — on the device submissions the reduction applies to. A tighter threshold, $30 million or less including affiliates, adds a separate benefit: a full waiver of the fee for the business's first premarket application or report, whether that's a PMA, a product development protocol, or a comparable first submission. A third, $1 million threshold, paired with a documented showing of financial hardship, can waive the registration fee outright. Each threshold is its own determination against its own number, not a single small-business status that automatically carries all three benefits with it.

The test is control, not an ownership percentage

Section 737(13) of the FD&C Act defines the affiliate whose revenue has to be added in, and it doesn't set a percentage that triggers the aggregation. It reaches any business that directly or indirectly controls, is controlled by, or is under common control with the applicant — a test built around the practical ability to control business decisions, not a fixed ownership line an applicant can engineer around. A minority-held subsidiary, a jointly governed entity, or a parent company on another continent can all count as affiliates under that standard, and once one does, its full gross receipts get added to the applicant's own, regardless of how small a stake the applicant holds in it.

Every affiliate, including the ones FDA can't see a tax return for

The aggregation runs globally, not just across domestic corporate structures. A foreign affiliate's gross receipts count exactly like a domestic one's — but FDA can't independently verify a number pulled from a foreign entity's internal books the way it can check a domestic tax filing, so the current combined form, FDA 3602N, requires that foreign figure to be certified by the National Taxing Authority in the affiliate's own country before FDA will accept it. A request built on an internal financial statement instead of that government certification isn't a weaker version of a complete filing — it's a filing FDA can't act on until the certification is supplied.

The determination expires on the fiscal year, not on the product

A granted determination is good for one fiscal year and expires on September 30 of that year, no matter when during the year it was issued. A device program that spans several fiscal years has to requalify every single year it wants the fee benefit applied, not once at the program's start — last year's approved determination doesn't carry forward on its own. FDA reviews a complete request within 60 calendar days, and because the determination has to already be in hand before the fee comes due rather than requested alongside it, the safer practice is filing well ahead of whatever submission the benefit is meant to cover, not the week the submission itself goes out.

Where this meets the file

A user-fee planning record needs the affiliate structure carried as its own tracked field — every entity that meets the 737(13) control test, its own gross receipts, and which of the three thresholds the combined total actually clears — rebuilt each fiscal year rather than copied forward from the last approval. A Small Business Determination worksheet built around that structure is previewed in the launch catalog. If your organization's affiliate structure has changed and you've tracked the recalculation differently, the shelf takes that correction directly.