FDA USER FEES for 2026

The following is the FDA user fees for the medical device industry for 2026.

As you can see the FDA is raising the FDA medical registration fee from $9280 to $11423. This is an increase of $2143 or 23%.
The 510(k) submission fee for a small business went up from $6084 to $6517, an increase of $443 (or 7%).

FDA Fee for Medical Device Registration and Applications for Fiscal Year 2026

Type of Registration / Application Standard Fees Small Business Fee
Medical Device Establishment Registration $11,423 $11,423
FDA 510(k) Submission $26,067 $6,517
FDA 513(g) Submission $7,820 $3,910
FDA PMA, PDP, PMR, BLA Submission $579,272 $144,818
De Novo Classification Request $173,782 $43,446
Panel-track Supplement $463,418 $115,855
180-Day Supplement $86,891 $21,723
Real-Time Supplement $40,549 $10,137
BLA Efficacy Supplement $579,272 $144,818
30-Day Notice $9,268 $4,634
Premarket report $579,272 $144,818
Annual Fee for Periodic Reporting on a Class III device (PMAs, PDPs, and PMRs) $20,275 $5,069

If you have any questions on this please let us know and email us at:
info@mdiconsultants.com and re: FDA user fees 2026.