Rule lifecycle · DOCKET:FDA-2018-D-1873
Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability
Department of Health and Human Services, Food and Drug Administration — observed across 3 documents over 525 days. Use the source documents below before deciding whether this affects your business.
In plain English
FDA releases guidance for device makers explaining exactly how to figure out if they're small enough to qualify for reduced or waived annual user fees. Check your company size and file a small business claim if you qualify—missing the deadline costs you thousands in annual fees.
First seen
Feb 22, 2024
Last seen
Jul 31, 2025
Latest stage
Notice
PRORULE → RULE
—
Stage timeline
Notice·Feb 22, 2024
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request
#2024-03619
Notice·Jun 9, 2025
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
#2025-10387
Notice·Jul 31, 2025
Medical Device User Fee Small Business Qualification and Determination Guidance Final Guidance for Industry and Food and Drug Administration Staff and Foreign Governments; Availability
#2025-14460