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공지 FY2023 FDA Medical Device User Fee 공지
등록일 : 2022-10-06    조회수 : 65

User Fees for FY2023

Annual Establishment Registration Fee: $6,493

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

Other fees for Fiscal Year 2023 (October 1, 2022 through September 30, 2023) are:

Application Type

Standard Fee

Small Business Fee

510(k)

$19,870

$4,967

513(g)

$5,961

$2,980

PMA, PDP, PMR, BLA

$441,547

$110,387

De Novo Classification Request

$132,464

$33,116

Panel-track Supplement

$353,238

$88,309

180-Day Supplement

$66,232

$16,558

Real-Time Supplement

$30,908

$7,727

BLA Efficacy Supplement

$441,547

$110,387

30-Day Notice

$7,065

$3,532

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

$15,454

$3,864

† 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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