The US Food and Drug Administration (FDA) issued CSMS message 17-000330 regarding their regulatory authority over light emitting diodes (LED) that are contained in bulbs, fixtures, and other products. These products emit visible optical radiation, which qualifies them to be radiation-emitting electronic products and gives FDA regulatory authority. As such, reporting to FDA upon importation of radiation-emitting electronic products is required.
This covers LED products used for general or local area illumination, such as lamps and lightbulbs, which are of special interest to FDA. This shipment information must be submitted to FDA for review. However, FDA does not expect the transmission of entry data for finished products which incorporate LEDs as indicator lights, such as in toys, tablets, cellular devices, IPads, shoes, household appliance and entertainment systems, remote controls, or other products not otherwise regulated by FDA in another capacity.
The tariff numbers impacted are 8541.40.2000 and 9405.10.4010 through 9405.40.8440.
The name and address (or MID code) of the manufacturer will be required on the documents at the time of entry. Please ensure that this information is shown on the entry documents at the time of entry if you are shipping an LED product. If this information is not present, your shipment will be placed on hold and your company will be contacted for the name and address of the manufacturer.
If you have questions regarding this requirement, please contact the Willson US regulatory Team via email: transitionus@willsonintl.044d949.netsolhost.com or phone 716-260-1971 (option 4) during regular business hours.
Questions related to the reporting requirements for LEDs may be submitted to FDA’s Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov