FDA certification

1、 What is FDA registration

FDA registration, also known as FDA registration. This refers to the process of exporting cosmetics, medical devices, food, lasers, LED lighting fixtures, and other products to the United States, which 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 of these products must also provide relevant testing to successfully register. For example, clinical Class II and Class III medical products must provide 510K documents to register with the FDA.

2、 Common Mistakes 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, which means that you are responsible for your product's compliance with relevant standards and safety requirements and register it on the US federal website. If the product has an accident, you must take corresponding responsibility. Therefore, for most products registered by FDA, there is no claim of sending samples for testing or issuing certificates. Therefore, the hype circulating online, such as Wahaha obtaining FDA certification and Quanjian products obtaining FDA certification to demonstrate the safety of their products, is a misconception. There is no situation where FDA certification is considered 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 fees involved also need to be paid again.

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

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3、 What are the differences between FDA registration, FDA testing, and FDA certification

It can be understood in this way,

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. Medicines

FDA certification is a collective 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 Trends in FDA Registration

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

According to industry insiders, LED lights have been included in the FDA's 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 irregular 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 if the product only uses LED lights but does not have LED lights, it needs to be clearly marked in the customs clearance materials.