1、 What is FDA registration

FDA registration, also known as FDA registration. This refers to the requirement that cosmetics, medical devices, food, lasers, LED lighting and other products exported to the United States must be registered with the Federal Food and Drug Administration and ensure that the products comply with relevant US standards and health and safety requirements. Some products must also undergo relevant testing to be successfully registered. For example, clinical Class II and Class III medical products must provide 510K documents to register with the FDA.

II Common Misconceptions in FDA Registration

1. FDA registration and CE certification are different, and their certification mode is different from the product testing+report certificate mode of CE certification. FDA registration actually adopts the integrity declaration mode, that is, you are responsible for your product's compliance with relevant standards and safety requirements, and register on the US federal website. If the product has an accident, you will be held responsible accordingly. Therefore, for most products, FDA registration does not involve sending samples for testing and issuing certificates. Therefore, the rumors circulating online that Wahaha has obtained FDA certification and Quanjian products have obtained FDA certification to demonstrate the safety of their products are all misunderstandings. There is no such thing as being FDA certified being high-end.

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

Does FDA registration have a certificate Actually, all actions of FDA registration are done online, and there is no such thing as a certificate. So what is the FDA certificate circulating in the market? In fact, it is a declaration document issued by the agency itself, proving that the product has been registered with the FDA. For example:

III What is the difference between FDA registration, FDA testing, and FDA certification

It can be understood as follows:,

FDA testing generally targets these types of products:

1. Class II and III medical devices;

2. Cosmetics and daily necessities;

3. Food contact materials;

FDA registration is generally divided into:

1. Cosmetics

2. LED and laser products

3. Medical devices

4. Food

5. Medications

FDA certification is a general term for FDA testing and FDA registration, both of which can be referred to as FDA certification. FDA certification is just a common saying.

4 Latest Developments in FDA Registration

Recently, LED lights will be included in the FDA regulatory scope. It is understood that after the implementation of this rule, LED light products may face dual "checkpoint" audits. In addition to customs clearance, FDA release may also be required during customs clearance. But this change only involves LED lights themselves, not products that use LED lights (such as lamps without LED lights themselves).

According to industry insiders, LED lights have been included in the FDA regulatory scope, and the requirements for the export logistics industry will be more stringent. When receiving customer goods, it is necessary to clarify the manufacturer and refuse to accept non-standard products. At the same time, when providing customs clearance materials, it is necessary to provide the manufacturer information of the LED lights, including the manufacturer's name, address, and contact phone number, to avoid customs clearance delays.

It is reported that products that only use LED lights but do not come with LED lights need to be clearly marked in the customs clearance materials.