FDA 注册 2025年度 Annual Establishment Registration 更新续费 User Fees for FY 2025
FDA 注册：Medical Device User Fee Amendments (MDUFA)
WEDA 威达检测提供全类型 FDA 注册服务: 13823190081
FDA企业注册，2025年度更新续费开始了，续费期为10月-12月31号，续费完成有效期至October 1, 2024 through September 30, 2025到12月底，10-12月继续续费下一年费用
2025年度FDA官方年费已出：
FDA注册企业（2025年度费用）美金 $9,280
WEDA/食品/化妆品/药品/激光产品/医疗产品/续费更新机构
2024年10月1日起可申请2025年度美国FDA注册。请需要继续使用FDA的客户及时联系，做好续费注册，以免逾期FDA不再提供更新之前的信息！
FDA注册续费及年费PIN码申请费用
目前FDA注册在中国的应用范围：
1）在FDA机构受管辖范围内的产品，上架美国亚马逊须办理FDA注册，例如：食品、化妆品产品 、医疗产品等.
2）在FDA机构受管辖范围内的产品，出口到美国，威达办理FDA注册，获取FDA注册号，否则无法清关.
3) 获取FDA注册号，能够更快的获得其他国外的客户对你们企业的认可度.
FDA注册包含以下种类：
1. 食品FDA注册申请DUNS
2. 激光产品类FDA注册
3. 医疗器械类FDA注册
4. 化妆品类FDA注册
5. 食品类FDA注册
6. 非处方药类OTC-NDC注册
User Fees for FY 2025
Annual Establishment Registration Fee: $9,280
All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups in FY 2025.
Other fees for Fiscal Year 2025 (October 1, 2024, through September 30, 2025) are:
| Application Type | Standard Fee | Small Business Fee† |
|---|---|---|
| 510(k)‡ | $24,335 | $6,084 |
| 513(g) | $7,301 | $3,650 |
| PMA, PDP, PMR, BLA | $540,783 | $135,196 |
| De Novo Classification Request | $162,235 | $40,559 |
| Panel-track Supplement | $432,626 | $108,157 |
| 180-Day Supplement | $81,117 | $20,279 |
| Real-Time Supplement | $37,855 | $9,464 |
| BLA Efficacy Supplement | $540,783 | $135,196 |
| 30-Day Notice | $8,653 | $4,326 |
| Annual Fee for Periodic Reporting on a Class III device (PMAs,PDPs, and PMRs) | $18,927 | $4,732 |
† Small Business Fee: For businesses certified by the Center for Devices and Radiological Health (CDRH) as a small business. For more information, see the section Small Businesses below.
‡ 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.
参照FDA法规要求，每年的10月1日到12月31日为进行下一年度更新续费的周期，如预期未能完成更新续费，到下期在FDA的注册信息不再更新。因此为确保公司FDA注册的信息在2025年继续有效，应及时更新续费。
