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FDA2023财年医疗器械官费标准已定,大幅增长!Annual Establishment Registration Fee: $6,493

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发表时间:2022-10-06 13:29

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FDA没有能够在9月30日,也就是2022年财政年度结束的最后一天前公布2023年度新的FDA医疗器械官费数额。不过,FDA也算给力,成功的游说参议院在9月30日这一天投票成功,使得MDUFA(也就是The Medical Device User Fee and Modernization Act)的第五版在拜登总统签字后正式成为法律。


2023年10月5日,FDA正式公布了2023财政年度的医疗器械官费数目。大家最关心的几项有:

  • 企业注册年费(Establishment Registration Fee):6493美金,比FDA向国会提交的草案中的6250美金略高。比起2022年度的5672美金涨价800多美金。

  • 510(K)审核费:正常收费19870美金,小企业减免到4967美金,比起2022年度的3186美金涨价1700多美金

  • 三类产品PMA的正常收费是441547美金,也比FDA向国会提交的草案中的425000美金略高。


每年10月1日到12月31日期间,企业需要更新FDA注册以确保下一年持续处于有效状态。


User Fees for FY2023

Annual Establishment Registration Fee: $6,493

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

Application TypeStandard FeeSmall 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.


完整的收费价目表可以在这个链接找到:

https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa?utm_medium=email&utm_source=govdelivery



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