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공지 FY2024 FDA Medical Device User Fee 공지
등록일 : 2023-08-18    조회수 : 461

User Fees for FY 2024

Annual Establishment Registration Fee: $7,653

All establishments must pay the establishment registration fee.
There are no waivers or reductions for small establishments, businesses, or groups in FY 2024.

Other fees for Fiscal Year 2024 (October 1, 2023, through September 30, 2024) are: 

 

Application Type

Standard Fee

Small Business Fee

510(k)

$21,760

$5,440

513(g)

$6,528

$3,264 

PMA, PDP, PMR, BLA

$483,560

$120,890

De Novo Classification Request

$145,068

$36,267

Panel-track Supplement

$386,848

$96,712

180-Day Supplement

$72,534

$18,134

Real-Time Supplement

$33,849

$8,462

BLA Efficacy Supplement

$483,560

$120,890

30-Day Notice

$7,737

$3,869

Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs)

$16,925

$4,231

 

 

† Small Business Fee: For businesses certified 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. 

 

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