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[미국FDA] 2023 미국 FDA 등록비용 FY 2023 - FDA Medical Device Registration Fees

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2022-10-20 21:21:55
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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, and PMRs)	$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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