Recently, there are LED product sellers said they received the Amazon logistics sales staff notice that May 1, 2017, LED products need to do FDA certification to export to the United States.
Really nervous some. However, after repeated communication with the FDA's official, the issue has been further clarified. "General LED lighting products imported US market only need to declare, do not need FDA certification, do not need to submit FDA Product Report product report, do not need to submit FDA Annual Report annual report, not Need to implement FDA certification performance standards ", which undoubtedly LED export enterprises and manufacturers of nervous nerves loose down. Please see below for your detailed FDA certification knowledge.
1, what is the FDA?
FDA, under the US Department of Health Education and Welfare, is responsible for the management of pharmaceuticals, food, biological products, cosmetics, veterinary drugs, medical devices and diagnostic supplies.
2, CDRH is what the FDA department?
The Center for Devices and Radiological Health referred to as the CDRH is a branch of the FDA's various departments for the protection and promotion of public health and the supplier's timely, sustained, safe, efficient, high quality medical equipment and safe radiation products The
3, what products in the mandatory FDA certification within the scope of control?
FDA General requirements include all LED products in US CFR 21 CFR 1000-1005 and need to be made available to the FDA, but LED lighting products such as ordinary LED lights are not subject to mandatory FDA certification within 21 CFR 1000.3. So the general import of LED lights in the US market does not need to submit FDA product reports and annual reports, do not need to implement FDA certified performance standards. Currently, the products are mandatory for laser radiation, X-ray, microwave and microwave products. These products have specific FDA certification performance standards and must submit FDA report and annual report.
4, what is the FDA-2877 form?
US FDA-2877 form is "Declaration of compliance with radiation control standards for imported electronic products", the full name of <DECLARATION FOR IMPORTED ELECTRONIC PRODUCTS SUBJECT TO RADIATION CONTROL STANDARDS>, please see the following statement:
Official link to the original FDA-2877 form:
Ordinary LED lighting manufacturers to import US customs clearance, only need to fill in the above FDA-2877 form, in the red box on the location of the A.2. Project fill: LED light is the general product and no FDA performance standard applicable. General radiological health requirement apply . [1000-1005]
5, FDA official clarification
In mid-April 2017, FDA CDRH officials clarified this issue many times, see the FDA official clarification as follows:
Any LED product is considered to be a product under FDA's authority under 21 CFR 1000-1005, all all LED products should be claimed to FDA.
LEDs are radiation-emitting products as defined in 21 CFR 1000.3.
A light (light-emitting diode) is a two-lead semiconductor light source that em sets visible light electromagnetic radiation. The product code is 95R-HH
There are no reporting requirements or applicable performance standards:
This means that LED lights are radiation cutting devices, but they are not subject to any reporting requirements, thus no 2877 form is required (Only A.2 claim no performance criteria).
6, expand knowledge
If your LED lighting product contains a laser function, it is required to perform FDA certification, test laser power and determine the laser level, and submit the FDA product report and submit the FDA annual report before September 1, due to the inclusion of the LASER laser, US Customs must complete FDA Accession number in the FDA-2877 form, to enter the US market.