Background

The Food and Drug Administration has issued the following guidance to address confusion regarding entry reporting requirements for light-emitting diode products and products containing LEDs.

- The FD flag for LEDs under HTSUS 8541.40.2000 is now set at FD2 and the FDA expects the transmission of entry data for products falling under this subheading. LED products used for general or local area illumination, such as lamps and light bulbs, are of special interest to the FDA and must be submitted for review. 

- The FDA does not expect the transmission of entry data for finished products that incorporate LEDs as indicator lights, such as toys, tablets, cellular devices, iPads, shoes, household appliance and entertainment systems, remote controls, or other products not otherwise regulated by the FDA in another capacity. These types of products do not fall under HTSUS 8541.40.2000 and are not indicated for entry submission to FDA.

The FDA has regulatory authority over radiation-emitting electronic products, which are defined in 21 CFR 1000.3 as any electrically-powered product that can emit any form of radiation on the electromagnetic spectrum. Reporting to the FDA upon importation of radiation-emitting electronic products is required. LED products emit visible optical radiation, which qualifies them to be radiation-emitting electronic products and gives the FDA regulatory authority over them.

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