I. What is FDA Registration?
FDA registration, also known as FDA filing, refers to the action that products such as cosmetics, medical devices, food, lasers, LED lighting fixtures, etc. must be registered with the U.S. Food and Drug Administration (FDA) when exported to the United States, and it is necessary to ensure that the products meet the relevant U.S. standards and health and safety requirements. For some products, relevant testing must also be carried out before successful registration. For example, Class II and Class III clinical medical products must provide a 510K document to register with the FDA.

II. Common Misunderstandings about FDA Registration

1. FDA registration is different from CE certification. Its certification mode is different from the product testing + report certificate mode of CE certification. In fact, FDA registration adopts a good-faith declaration mode, that is: you are responsible for your product's compliance with relevant standards and safety requirements and register it on the official U.S. federal website. If something goes wrong with the product, you need to bear the corresponding responsibilities. Therefore, for most products under FDA registration, there is no such thing as sending samples for testing and issuing certificates. Thus, the widely spread claims on the Internet, such as Wahaha obtaining FDA certification and Quan Jian products obtaining FDA certification to show the safety of their products, are all misunderstandings. There is no situation that doing FDA registration makes a product seem very high-end.

2. The validity period of FDA registration: The validity period of FDA registration is one year. If it exceeds one year, the registration needs to be submitted again, and the annual fee involved also needs to be paid again.

3. Is there an FDA registration certificate? In fact, all actions of FDA registration are done by making entries on the Internet, and there is no so-called certificate. Then what are the so-called FDA certificates circulating in the market? In fact, they are all declarative documents issued by the agency itself to prove that the product has been registered with the FDA. For example:

III. What are the Differences among FDA Registration, FDA Testing, and FDA Certification?
It can be understood in this way.
FDA testing generally applies to the following types of products:

1. Class II and Class III medical devices;

2. Cosmetics and daily necessities;

3. Food contact materials;
FDA registration is generally divided into:

4. Cosmetics

5. LED and laser products

6. Medical devices

7. Food

8. Pharmaceuticals
FDA certification is a general term for FDA testing and FDA registration. Both of them can be called FDA certification, and FDA certification is just a common term.

IV. The Latest Developments of FDA Registration
Recently, LED lights will be included in the scope of FDA supervision. It is understood that after this regulation comes into effect, LED light products may face double "checkpoints" for review. When going through customs clearance, in addition to the need for customs approval, they may also need to be released by the FDA. However, this change only involves the LED lights themselves and does not involve the commodities using LED lights (such as lighting fixtures that do not have the LED lights themselves).
According to industry insiders, the inclusion of LED lights in the scope of FDA supervision will impose more stringent requirements on the export logistics industry. It needs to clarify the manufacturers when receiving customers' goods and refuse to receive unqualified products. At the same time, when providing customs clearance materials, the information of the LED light manufacturers, including the manufacturer's name, address, and contact number, needs to be provided together to avoid customs clearance delays.
It is reported that if a product only uses LED lights but does not have the LED lights themselves, it is necessary to clearly indicate this in the customs clearance materials.