经过邮件与FDA网站联系后学习得到一些相关信息。
· FDA重要提醒声明，原文参考此链接。
· 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.
如果您的产品需要认证，欢迎联系深圳安博检测股份有限公司
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电动牙刷法规的一般要求：
使用FDA法规标准：
提交注册型：
|
Submission
Type
|
510(K) Exempt
|
电动牙刷属于医疗器械Class
I，Class
I devices are subject to general
controls.
|
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.
|
|
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.
|
根据这段话，电动牙刷使用的标准为：21
CFR
parts 872.6865，在豁免条款里面，我们只需要做注册就好，有链接参考。
值得注意的是 FDA注册需要美国代理商，4884美金。FDA注册是没有证书的，产品通过在FDA进行注册，将取得注册号码，FDA会给申请人一份回函（有FDA行政长官的签字），但不存在FDA证书一说。FDA是一个执法机构，而不是服务机构，FDA既没有面向公众的服务性认证机构与实验室，也没有所谓的“指定实验室”。
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