“你的LED灯上架了吗？ 请火速撤回!”

LED lights are FDA regulated:

（译文：LED灯属FDA监管）

“LED products emit visible optical radiation which qualifies them to be a radiation emitting electronic product and unless it contains a laser, these LED products are not subject to a mandatory standard but the FDA does regulate them.

译文：LED产品发射可见光辐射，使其成为辐射电子产品，除非它含有激光，这些LED产品不受强制性标准，但FDA对它们进行规范监管。

We recommend the manufacturer/importer to claim any product that we regulate and since we regulate all radiation emitting electronic products under the general/defect clause they should all be claimed. The LED manufacturers are subject to the ARO reporting requirement (21 CFR 1002.20) and notification if they discover a defect (21 CFR 1003). The product code we recommend the firms to transmit is shown below;

Since LEDs do not have a performance standard, a 2877 Form shouldn’t be required but you may still need to enter an Affirmation of Compliance of RA2 and state “There is no performance standard”.

译文：我们要求制造商/进口商向我们申报任何属于我们规管的产品，因为根据一般/缺陷条款，我们规管的所有辐射的电子产品都应该申报。 

LED厂商，如果发现一个缺陷（21 CFR 1003），受ARO报告要求（21 CFR 1002.20）和通知管制。我们建议公司使用的产品代码如下所示；

由于LED没有性能标准，可能不需要填写2788表格，但你可能依然需要填写一份表格，An Affirmation of Compliance of RA2 并声明“没有性能标准”。

ORA imports product code is:

译文：ORA进口产品编码

 非装置发光产品：LED, 照明，一般光学产品，非医疗用，                  

 编码：95R--HH

Here is additional information on LED product code taken off our website:

（译文：下面是从我们网站上下载的关于LED产品的附加信息）

上图译文： 

产品：LED 灯

定义：发光二极管光源

产品描述：一般光学产品/非医疗用

产品编码：RHH

辐射类型：光

是否需要辐射安全报告？  不需要

是否需要年度报告？  不需要

适用的性能标准：无适用标准。一般放射卫生要求（1000-1005）

Also, check out our website where it discusses LEDs: 

（译文：可以查看FDA网站上关于论述LED产品的信息：）

http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/default.htm

Product Specific Questions

Q35) Are Light Emitting Diodes (LEDs) or Intense Pulsed Lights (IPLs) subject to the laser regulations and reporting?

LEDs and IPLs do not meet the definition of a laser, namely:

21 CFR 1040.10(b)(19) Laser means any device that can be made to produce or amplify electromagnetic radiation at wavelengths greater than 250 nm but less than or equal to 13,000 nm or, after August 20, 1986, at wavelengths equal to or greater than 180 nm but less than or equal to 1.0*106nm primarily by the process of controlled stimulated emission.

There is no existing FDA performance standard for LED or IPL products. They are not subject to Product or Annual reports under 21 CFR 1002. However, as they are radiation-emitting products, the manufacturers of these products would still be subject to the general requirements in Title 21 CFR 1000 through 1005, specifically, accidental radiation occurrence notifications and notifications of defect, 21 CFR 1003 & 1004.

译文：

产品具体问题

Q35）发光二极管（LEDs）或强脉冲光（IPLs）是否受激光法规和报告管制？

LEDs和IPLs不满足激光的定义，即：

21 CFR 1040.10（b）（19）激光设备，能够产生或放大电磁辐射的波长大于250 nm，但小于或等于13000纳米，1986年8月20日后，主要通过控制激光发射过程，在波长等于或大于180 nm，但小于或等于1.0* 106nm。

对于LED或者IPL产品，FDA没有现存的性能标准。根据21 CFR 1002，他们不受产品报告或年度报告管制。然而，因为它们是辐射发光产品，这些产品的制造商仍然受到21 CFR 1000的一般要求管制，具体来说，通过1005，做出意外辐射发生的通知和缺陷的通知，21 CFR 1003。