發布日期：2022-10-06
在各種因素影響下美國FDA 2023年度醫療器械官費沒能在2022財年結束前如期公布，為不影響每年10月1日至12月31日期間相關企業的年度續費更新，FDA成功游說參議院在9月30日完成投票，并在拜登總統簽字后成為法律。
2023年10月5日FDA在其官網上公布了2023財年醫療器械企業年費和各項服務收費標準。
其中大家比較關心的FDA企業注冊和器械列名的年費和510(K) 申報費用都有比較大幅的提高。
2023財年的企業年費為$6,493，較2022財年$5,672上漲14.47%。
510（k）的審評費$19,870，較2022財年$12,745上漲55.9%。
詳細對比如下。
|
申請類型 |
2023年 |
2022年 |
||
|
標準收費 |
小企業收費 |
標準收費 |
小企業收費 |
|
|
企業注冊年費 |
$6,493 |
$6,493 |
$5,672 |
$5,672 |
|
510（K）費用 |
$19,870 |
$4,967 |
$12,745 |
$3,186 |
小企業說明：FDA規定的小企業指的是公司最近稅收年度的總收入或銷售額未超過1億美金，符合條件的企業需要提前1-2個月申請FDA小企業資質認證后才能享受相關優惠。
FDA 2023財年醫療器械各種收費如下：
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.
詳情敬請查看FDA官網鏈接：
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
