CSMS #17-000330 published on June 6, 2016 provides clarification regarding the regulation of LEDs under the FDA. Per the statement:
Reporting to 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 FDA regulatory authority.
For more information on this read the below CSMS message as well as the letter sent by the FDA to the NCBFAA regarding the reporting requirements (last link).
Completed text of CSMS #17-000330. Important portions are bolded:
SUBJECT: Update on Light-emitting diode (LED) Reporting to FDA
The US Food & Drug Administration (FDA) is providing this update to clarify expectations regarding Light-emitting diodes (LED) reporting.
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. As such, reporting to 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 FDA regulatory authority. The level of information to be provided varies based on whether there is a performance standard, but the general regulatory authority remains with FDA.
Recently, FDA became aware that information was not being transmitted to FDA for review of imported LED products. To rectify this, FDA updated the FD Flag for LEDs under HTS code 8541.40.2000, which is now set at FD2. FDA expects the transmission of entry data for products falling under this HTS code. LED products used for general or local area illumination, such as lamps and lightbulbs, are of special interest to FDA and 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. These types of products do not fall under HTS code 8541.40.2000 and are not indicated for entry submission to FDA.
FDA is issuing this explanation to address the evident confusion regarding the entry transmission expectations for LED products and products containing LEDs. FDA hopes this message will alleviate some of these concerns and lessen the burden this misinterpretation has caused the import community.
FDA is issuing this message as part of its continued outreach efforts to assist the importing community; please make this information available to importers of record, consignees, manufacturers, shippers and other stakeholders that may be affected by FDA import requirements.
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.
Additional references regarding Light-emitting diode (LED) reporting: https://www.fda.gov/radiation-emittingproducts/electronicproductradiationcontrolprogram/gettingaproducttomarket/default.htm
FDA Response Letter to NCBFAA – Detailed Response to the National Customs Brokers and Freight Forwarders Association regarding the reporting requirements for LEDs.