Recently, some media reported that LED lights will be included in the scope of FDA supervision.
It is understood that after the implementation of this rule, LED light products will face a double "level check" review, in addition to customs clearance, customs clearance may also require FDA release. However, this change only involves the LED lamp itself, and does not involve the use of LED lights (such as lamps without the LED lamp itself).
According to industry insiders, LED lights are included in the FDA's regulatory scope, and the requirements for the export logistics industry will be more stringent. They need to be clear about the manufacturers and refuse to accept irregular products when receiving customer goods.
At the same time, when providing customs clearance materials, it is necessary to provide the manufacturer information of the LED lamps together, including the manufacturer's name, address and contact number, so as to avoid delays in customs clearance. If you only use LED lights but do not have LED lights, please clearly mark them in the customs clearance materials.
According to the industry insiders, this regulation has only just begun to be implemented, so it should not be checked too strictly in the future.
In 1968, the US government issued the Radiation Control for Health and Safety Act. The law is to protect the public from unnecessary radiation damage from electronic products.
To this end, the FDA has established relevant performance standards for the radiation of electronic products, and it is mandatory that the radiation electronic products entering the US market must comply with relevant performance standards.
Radiant solar lamps, ultraviolet lamps and high-intensity mercury vapor discharge lamps in luminaires must meet FDA requirements. The FDA's requirements for radiating luminaires are primarily included in 21 CFR part 1040 of the US Code of Federal Regulations.
The US inspection and supervision of import inspection of radioactive products is also the responsibility of the US Food and Drug Administration (FDA). FDA requires foreign manufacturers of radioactive products to submit FDA-approved materials to their products before they are sold to the United States. The FDA then assigns a 7-digit number, which is equivalent to the FDA registration number of the foreign manufacturer.
Importers must also report to the FDA in accordance with the FDA 2877 form (electronic product declaration form) in addition to reporting to the customs at the time of importation of the radioactive product. In addition to the relevant information of the manufacturer, importer, and products, the declaration form requires the registration number of the above-mentioned foreign manufacturer in the FDA. If the application materials are incomplete or do not meet the requirements, they are directly rejected by the FDA. Even if the customs approves the release, they cannot enter the US market.
In addition to reviewing the application materials, the FDA has the right to conduct sampling and inspection before or after it enters the market to check whether the imported product meets the mandatory requirements of the relevant US regulations, and the FDA will strictly handle the illegal products.
There are two types of FDA penalties: detention of illegal products, return to foreign countries, and local destruction. Similar to medical devices, there are also “automatic detainment†systems for illegal electronic products. Seriously, according to relevant laws and regulations, it can be fined or sentenced or both.
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