FDA Small Business Determination

Are you an FDA small business? If you qualify, most device review fees drop to a quarter of the standard rate. But you have to apply, and reapply every year. The test is revenue. If your business, with all affiliates, had gross receipts or sales of $100 million or less in its latest tax year, you can qualify for reduced fees. In fiscal year 2027, a 510(k) costs $7,163 instead of $28,653. Two more lines matter. At $30 million or less, your first PMA fee can be waived. The $13,785 registration fee is never reduced; it can only be waived at $1 million or less, with proven hardship and a fee paid before. Timing is the trap. Status lasts one fiscal year and expires on September 30. If you submit before FDA grants it, you pay the full fee, with no refund later. Start with three things. One: count receipts across all affiliates. Two: file your request in the CDRH Portal, at least 60 days before any fee. Three: reapply every August for the next year. Qualify first, then pay less. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.