FDA Publishes Medical Device User Fees for Fiscal Year 2025

On July 31, 2024, the U.S. Food and Drug Administration (FDA) posted a Federal Register notice announcing the Medical Device User Fee Rates for Fiscal Year 2025. The fees have increased by 11.8%, with the exception of the establishment registration fee, which increased by 21.3%. The increased fees will be effective October 1, 2025. You can find the new Medical Device User Fees in the table below.

Medical Device User Fee Rates for Fiscal Year 2025

Application Fee Type	FY 2025 Standard Fee	FY 2025 Small Business Fee
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))	$540,783	$135,196
Premarket report (submitted under section 515(c)(2) of the FD&C Act)	$540,783	$135,196
Panel-track supplement	$432,626	$108,157
De novo classification request	$162,235	$40,559
180-day supplement	$81,117	$20,279
Real-time supplement	37,855	$9,464
510(k) premarket notification submission	24,335	$6,084
30-day notice	8,653	$4,326
513(g) request for classification information	$7,301	$3,650
Annual fee for periodic reporting on a class III device	$18,927	$4,732
Annual establishment registration fee	$9,280	$9,280

To view the Federal Register notice, click here.