2026/10/6

Application Type                                           Standard Fee       Small Business Fee*

                                                                           (U.S. Dollars)            (U.S. Dollars)

510(k)**                                                             $28,653               $7,163

513(g)                                                             $8,596               $4,298

PMA, PDP, PMR, BLA                                     $636,732               $159,183

De Novo Classification Request                    $191,020               $47,755

Panel-track Supplement                             $509,386               $127,347

180-Day Supplement                                     $95,510               $23,878

Real-Time Supplement                                     $44,571               $11,143

BLA Efficacy Supplement                             $636,732               $159,183

30-Day Notice                                             $10,188               $5,094

Annual Fee for Periodic Reporting                  $22,286               $5,57 

on a Class III device 

(PMAs, PDPs, and PMRs)

* Small Business Fee: For businesses qualified by the Center for Devices and Radiological Health (CDRH) as a small business.

**510(k) Fees: All types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.