電動牙刷類產品出口美國做FDA認證詳解，FDA認證容易過嗎
經過郵件與FDA網站聯系后學習得到一些相關信息。
· FDA重要提醒聲明，原文參考此鏈接。
· FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process.
如果您的產品需要認證，歡迎聯系深圳安博檢測股份有限公司
電動牙刷法規的一般要求：
使用FDA法規標準：
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Regulation Number |
872.6865 |
提交注冊型：
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Submission Type |
510(K) Exempt |
電動牙刷屬于**器械Class I，Class I devices are subject to general controls.
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Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
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If a manufacturer"s device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
根據這段話，電動牙刷使用的標準為：21 CFR parts 872.6865，在豁免條款里面，我們只需要做注冊就好，有鏈接參考。
值得注意的是 FDA注冊需要美國代理商，4884美金。FDA注冊是沒有證書的，產品通過在FDA進行注冊，將取得注冊號碼，FDA會給申請人一份回函（有FDA行政長官的簽字），但不存在FDA證書一說。FDA是一個執法機構，而不是服務機構，FDA既沒有面向公眾的服務性認證機構與實驗室，也沒有所謂的“實驗室”。
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